An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (FOCUS)

November 5, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments

The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
838

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Teva Investigational Site 37092
      • Brussels, Belgium, 1090
        • Teva Investigational Site 37089
      • Hasselt, Belgium, 3500
        • Teva Investigational Site 37091
      • Liege, Belgium, 4000
        • Teva Investigational Site 37090
  • Czechia
      • Brno, Czechia, 602 00
        • Teva Investigational Site 54162
      • Ostrava, Czechia, 70200
        • Teva Investigational Site 54159
      • Ostrava-Moravska, Czechia, 702 00
        • Teva Investigational Site 54165
      • Pardubice, Czechia, 53002
        • Teva Investigational Site 54158
      • Prague, Czechia, 100 00
        • Teva Investigational Site 54163
      • Prague 4, Czechia, 140 59
        • Teva Investigational Site 54164
      • Praha 10, Czechia, 160 00
        • Teva Investigational Site 54160
      • Praha 3, Czechia, 130 00
        • Teva Investigational Site 54161
      • Praha 8, Czechia, 186 00
        • Teva Investigational Site 54166
      • Rychnov nad Kneznou, Czechia, 51601
        • Teva Investigational Site 54157
  • Denmark
      • Aalborg, Denmark, 9000
        • Teva Investigational Site 39051
      • Arhus, Denmark, 8000
        • Teva Investigational Site 39049
      • Ballerup, Denmark, 2750
        • Teva Investigational Site 39052
      • Glostrup, Denmark, 2600
        • Teva Investigational Site 39048
      • Vejle, Denmark, 7100
        • Teva Investigational Site 39050
  • Finland
      • Helsinki, Finland, 00180
        • Teva Investigational Site 40034
      • Helsinki, Finland, 00930
        • Teva Investigational Site 40035
      • Oulu, Finland, 90100
        • Teva Investigational Site 40036
      • Tampere, Finland, FI-33100
        • Teva Investigational Site 40033
      • Turku, Finland, 20100
        • Teva Investigational Site 40032
      • Turku, Finland, 20520
        • Teva Investigational Site 40037
  • France
      • Bron Cedex, France, 69677
        • Teva Investigational Site 35237
      • Lille, France, 59037
        • Teva Investigational Site 35238
      • Marseille, France, 13005
        • Teva Investigational Site 35235
      • Nice, France, 06000
        • Teva Investigational Site 35240
      • Strasbourg, France, 67098
        • Teva Investigational Site 35239
      • Voiron, France, 38500
        • Teva Investigational Site 35236
  • Germany
      • Berlin, Germany, 10177
        • Teva Investigational Site 32697
      • Berlin, Germany, D-10435
        • Teva Investigational Site 32690
      • Bochum, Germany, 44787
        • Teva Investigational Site 32694
      • Essen, Germany, 45147
        • Teva Investigational Site 32699
      • Goppingen, Germany, 73033
        • Teva Investigational Site 32692
      • Halle, Germany, 06120
        • Teva Investigational Site 32691
      • Hamburg, Germany, 20251
        • Teva Investigational Site 32698
      • Kiel, Germany, 24149
        • Teva Investigational Site 32700
      • Konigstein im Taunus, Germany, 61462
        • Teva Investigational Site 32695
      • Muenchen, Germany, 81377
        • Teva Investigational Site 32689
      • Rostock, Germany, 18147
        • Teva Investigational Site 32701
      • Ulm, Germany, 89073
        • Teva Investigational Site 32693
  • Italy
      • Firenze, Italy, 50134
        • Teva Investigational Site 30199
      • Roma, Italy, 00128
        • Teva Investigational Site 30204
  • Netherlands
      • Amsterdam, Netherlands, 1078VV
        • Teva Investigational Site 38126
      • Blaricum, Netherlands, 1261 AN
        • Teva Investigational Site 38127
      • Leiden, Netherlands, 2333 ZA
        • Teva Investigational Site 38124
      • Tilburg, Netherlands, 5042 AD
        • Teva Investigational Site 38125
  • Poland
      • Krakow, Poland, 31-209
        • Teva Investigational Site 53420
      • Krakow, Poland, 33-332
        • Teva Investigational Site 53425
      • Lodz, Poland, 90-338
        • Teva Investigational Site 53422
      • Lodz, Poland, 90-368
        • Teva Investigational Site 53424
      • Lublin, Poland, 20-022
        • Teva Investigational Site 53418
      • Poznan, Poland, 60-529
        • Teva Investigational Site 53416
      • Szczecin, Poland, 70-111
        • Teva Investigational Site 53419
      • Warszawa, Poland, 00-909
        • Teva Investigational Site 53417
      • Warszawa, Poland, 04-730
        • Teva Investigational Site 53423
  • Spain
      • Barcelona, Spain, 08035
        • Teva Investigational Site 31231
      • Madrid, Spain, 28223
        • Teva Investigational Site 31235
      • Madrid, Spain, 28942
        • Teva Investigational Site 31236
      • Pamplona, Spain, 31008
        • Teva Investigational Site 31226
      • Santander, Spain, 39008
        • Teva Investigational Site 31229
      • Santiago de Compostela, Spain, 15706
        • Teva Investigational Site 31230
      • Sevilla, Spain, 41013
        • Teva Investigational Site 31234
      • Valencia, Spain, 46010
        • Teva Investigational Site 31233
      • Valencia, Spain, 46026
        • Teva Investigational Site 31227
      • Valladolid, Spain, 47003
        • Teva Investigational Site 31225
      • Zaragoza, Spain, 50009
        • Teva Investigational Site 31228
  • Sweden
      • Helsingborg, Sweden, 252 20
        • Teva Investigational Site 42050
      • Huddinge, Sweden, 141 86
        • Teva Investigational Site 42049
      • Lund, Sweden, 260 83
        • Teva Investigational Site 42051
      • Stockholm, Sweden, 112 81
        • Teva Investigational Site 42052
      • Stockholm, Sweden, 114 33
        • Teva Investigational Site 42054
  • Switzerland
      • Bad Zurzach, Switzerland, 5330
        • Teva Investigational Site 45018
      • Bern, Switzerland, 3010
        • Teva Investigational Site 45016
      • Lugano, Switzerland, 6900
        • Teva Investigational Site 45017
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Teva Investigational Site 34231
      • Hull, United Kingdom, HU3 2JZ
        • Teva Investigational Site 34232
      • London, United Kingdom, SE5 9NT
        • Teva Investigational Site 34233
      • Oxford, United Kingdom, OX3 9DU
        • Teva Investigational Site 34230
      • Salford, United Kingdom, M6 8HD
        • Teva Investigational Site 34235
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Teva Investigational Site 34236
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Teva Investigational Site 14742
    • California
      • Long Beach, California, United States, 90806
        • Teva Investigational Site 14729
      • San Diego, California, United States, 92103
        • Teva Investigational Site 14739
      • Santa Monica, California, United States, 90404
        • Teva Investigational Site 14843
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Teva Investigational Site 14749
    • Florida
      • Maitland, Florida, United States, 32751
        • Teva Investigational Site 14758
      • Orlando, Florida, United States, 32819
        • Teva Investigational Site 14738
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Teva Investigational Site 14760
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Teva Investigational Site 14737
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Teva Investigational Site 14730
      • Evanston, Illinois, United States, 60201
        • Teva Investigational Site 14740
    • Kentucky
      • Louisville, Kentucky, United States, 40223
        • Teva Investigational Site 14735
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Teva Investigational Site 14747
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Teva Investigational Site 14750
      • Watertown, Massachusetts, United States, 02472
        • Teva Investigational Site 14734
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Teva Investigational Site 14731
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Teva Investigational Site 14748
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Teva Investigational Site 14746
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Teva Investigational Site 14754
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Teva Investigational Site 14752
    • New York
      • Amherst, New York, United States, 14226
        • Teva Investigational Site 14753
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Teva Investigational Site 14736
      • Greensboro, North Carolina, United States, 27408
        • Teva Investigational Site 14741
      • Raleigh, North Carolina, United States, 27607
        • Teva Investigational Site 14732
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Teva Investigational Site 14761
      • Warwick, Rhode Island, United States, 02886
        • Teva Investigational Site 14756
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Teva Investigational Site 14745
      • Nashville, Tennessee, United States, 37203
        • Teva Investigational Site 14743
    • Texas
      • Austin, Texas, United States, 78731
        • Teva Investigational Site 14733
    • Utah
      • West Jordan, Utah, United States, 84088
        • Teva Investigational Site 14751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The participant has a diagnosis of migraine with onset at ≤50 years of age.
  • Body weight ≥45 kilograms.
  • The participant has a history of migraine for ≥12 months prior to screening.
  • Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)

  • Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [that is; vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).

    • Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

  • At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
  • Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
  • The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
  • The participant uses triptans/ergots as preventive therapies for migraine.

  • Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.

    • Additional criteria apply, please contact the investigator for more information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Double-blind (DB) period: Participants with CM or EM will receive 3 injections of placebo 1.5 milliliters (mL) SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. Open-label (OL) period: Participants with CM or EM will receive fremanezumab (TEV-48125) 225 milligrams (mg) SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Drug: Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm.
Other Names:
  • TEV-48125
Drug: Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Experimental: Fremanezumab Quarterly
DB period: Participants with CM or EM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Drug: Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm.
Other Names:
  • TEV-48125
Drug: Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Experimental: Fremanezumab Monthly
DB period: Participants with CM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Drug: Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm.
Other Names:
  • TEV-48125
Drug: Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day -1), up to Week 12
A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value.
Baseline (Day -28 to Day -1), up to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DB Period: Percentage of Participants Reaching at Least 50 Percent (%) Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day-1), up to Week 12
A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28.
Baseline (Day -28 to Day-1), up to Week 12
DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day -1), up to Week 12
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects and baseline number of headache days of at least moderate severity and years since onset of migraine as covariates.
Baseline (Day -28 to Day -1), up to Week 12
DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day -1), up to Week 4
A migraine day was defined as when at least 1 of following occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day demonstrating a headache of any duration that was treated with migraine-specific medications. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.
Baseline (Day -28 to Day -1), up to Week 4
DB Period: Percentage of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day-1), up to Week 4
A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28.
Baseline (Day -28 to Day-1), up to Week 4
DB Period: Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day -1), up to Week 12
Baseline data and the mean change from baseline in the monthly average number of days of use of any acute headache medications during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.
Baseline (Day -28 to Day -1), up to Week 12
DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period After the First Dose of Fremanezumab
Time Frame: Baseline (Day -28 to Day -1), up to Week 4
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of headache days of at least moderate severity and years since onset of migraines as covariates.
Baseline (Day -28 to Day -1), up to Week 4
DB Period: Number of Participants With Adverse Events (AEs) and Who Did Not Complete the Study Due to AEs
Time Frame: Baseline (Day 0) up to Week 12
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline (Day 0) up to Week 12
OL Period: Number of Participants With AEs and Who Did Not Complete the Study Due to AEs
Time Frame: Week 12 up to Week 24
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Week 12 up to Week 24
DB Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results
Time Frame: Baseline up to Week 12
Criteria for potentially clinically significant abnormal serum chemistry values included: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) (units/liter [U/L]): greater than or equal to (≥) 3*upper limit of normal (ULN); Blood Urea Nitrogen (BUN): ≥10.71 millimoles/liter (mmol/L); creatinine: ≥177 micromoles/liter (µmol/L); bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline up to Week 12
OL Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results
Time Frame: Week 12 up to Week 24
Criteria for potentially clinically significant abnormal serum chemistry values included: ALT, AST, ALP, GGT, and LDH (U/L): ≥3*ULN; BUN: ≥10.71 mmol/L; creatinine: ≥177 µmol/L; bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Week 12 up to Week 24
DB Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results
Time Frame: Baseline up to Week 12
Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: less than (<) 115 grams/liter (g/L) (in men) or less than or equal to (≤) 95 g/L (in women), hematocrit: <0.37 L/L (in men) or <0.32 L/L (in women), leukocytes: ≥20*10^9/L or ≤3*10^9/L, eosinophils: >=10%, platelets: ≥700*10^9/L or ≤75*10^9/L, and absolute neutrophil count (ANC): ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline up to Week 12
OL Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results
Time Frame: Week 12 up to Week 24
Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: <115 g/L (in men) or ≤95 g/L (in women), hematocrit: <0.37 L/L (in men) or <0.32 L/L (in women), leukocytes: ≥20*10^9/L or ≤3*10^9/L, eosinophils: >=10%, platelets: ≥700*10^9/L or ≤75*10^9/L, and ANC: ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Week 12 up to Week 24
DB Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results
Time Frame: Baseline up to Week 12
Criteria for potentially clinically significant abnormal coagulation values included: prothrombin international normalized ratio (INR): greater than (>) 1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline up to Week 12
OL Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results
Time Frame: Week 12 up to Week 24
Criteria for potentially clinically significant abnormal coagulation values included: prothrombin INR: >1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Week 12 up to Week 24
DB Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results
Time Frame: Baseline up to Week 12
Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (milligrams/deciliter [mg/dL]): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline up to Week 12
OL Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results
Time Frame: Week 12 up to Week 24
Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (mg/dL): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Week 12 up to Week 24
DB Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Time Frame: Baseline up to Week 12
Criteria for potentially clinically significant abnormal vital signs values included: pulse rate: ≤50 beats/minute (bpm) and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure: ≤90 millimeters of mercury (mmHg) and decrease of ≥20 mmHg, or ≥180 mmHg and increase of ≥20 mmHg; diastolic blood pressure: ≤50 mmHg and decrease of ≥15 mmHg or ≥105 mmHg and increase of ≥15 mmHg; respiratory rate: <10 breaths/minute; and body temperature ≥38.3 degrees celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline up to Week 12
OL Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Time Frame: Week 12 up to Week 24
Criteria for potentially clinically significant abnormal vital signs values included: pulse rate: ≤50 bpm and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure: ≤90 mmHg and decrease of ≥20 mmHg, or ≥180 mmHg and increase of ≥20 mmHg; diastolic blood pressure: ≤50 mmHg and decrease of ≥15 mmHg or ≥105 mmHg and increase of ≥15 mmHg; respiratory rate: <10 breaths/minute; and body temperature ≥38.3 degrees celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Week 12 up to Week 24
DB Period: Number of Participants With Shift From Baseline to Week 12 in Electrocardiogram (ECG) Parameters
Time Frame: Baseline, Week 12
ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - Week 12 value. Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline, Week 12
OL Period: Number of Participants With Shift From Baseline to Week 24 in ECG Parameters
Time Frame: Baseline, Week 24
ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - Week 24 value. Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline, Week 24
DB Period: Number of Participants Who Received Concomitant Medications for Adverse Events
Time Frame: Baseline up to Week 12
Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.
Baseline up to Week 12
OL Period: Number of Participants Who Received Concomitant Medications for Adverse Events
Time Frame: Week 12 up to Week 24
Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.
Week 12 up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV48125-CNS-30068
  • 2017-002441-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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