Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

November 6, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

Study Overview

Status

Completed

Conditions

Migraine

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1130

Phase

Phase 3

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

Canada
- - Calgary, Canada, T3M 1M4
    - Teva Investigational Site 11120
  - Calgary, Canada
    - Teva Investigational Site 11120
  - Montreal, Canada, H2W 1V1
    - Teva Investigational Site 11121
  - Montreal, Canada
    - Teva Investigational Site 11121
  - Newmarket, Canada, L3Y5G8
    - Teva Investigational Site 11122
  - Newmarket, Canada
    - Teva Investigational Site 11122
  - Sarnia, Canada, N7T 4X3
    - Teva Investigational Site 11123
  - Sarnia, Canada
    - Teva Investigational Site 11123
- Ontario
  - Hamilton, Ontario, Canada, L8N 1Y2
    - Teva Investigational Site 11124
  - Hamilton, Ontario, Canada
    - Teva Investigational Site 11124
Czechia
- - Brno, Czechia, 602 00
    - Teva Investigational Site 54144
  - Brno, Czechia
    - Teva Investigational Site 54144
  - Kunratice, Czechia, 14800
    - Teva Investigational Site 54141
  - Kunratice, Czechia
    - Teva Investigational Site 54141
  - Pardubice, Czechia, 53002
    - Teva Investigational Site 54145
  - Pardubice, Czechia
    - Teva Investigational Site 54145
  - Prague 4, Czechia, 140 59
    - Teva Investigational Site 54142
  - Prague 4, Czechia
    - Teva Investigational Site 54142
  - Praha, Czechia, 100 00
    - Teva Investigational Site 54143
  - Praha, Czechia
    - Teva Investigational Site 54143
  - Praha 3, Czechia, 130 00
    - Teva Investigational Site 54146
  - Praha 3, Czechia
    - Teva Investigational Site 54146
Finland
- - Helsinki, Finland, 00100
    - Teva Investigational Site 40018
  - Helsinki, Finland, 00930
    - Teva Investigational Site 40017
  - Helsinki, Finland
    - Teva Investigational Site 40017
  - Helsinki, Finland
    - Teva Investigational Site 40018
  - Turku, Finland, 20100
    - Teva Investigational Site 40016
  - Turku, Finland
    - Teva Investigational Site 40016
Israel
- - Holon, Israel, 58100
    - Teva Investigational Site 80096
  - Holon, Israel
    - Teva Investigational Site 80096
  - Jerusalem, Israel, 9112001
    - Teva Investigational Site 80099
  - Jerusalem, Israel
    - Teva Investigational Site 80099
  - Nahariya, Israel, 221001
    - Teva Investigational Site 80098
  - Netanya, Israel, 4244916
    - Teva Investigational Site 80097
  - Netanya, Israel
    - Teva Investigational Site 80097
  - Ramat Gan, Israel, 5262160
    - Teva Investigational Site 80100
  - Ramat Gan, Israel
    - Teva Investigational Site 80100
  - Tel Aviv, Israel, 64239
    - Teva Investigational Site 80095
Japan
- - Chofu-shi, Japan, 182-0006
    - Teva Investigational Site 84072
  - Chofu-shi, Japan
    - Teva Investigational Site 84064
  - Chofu-shi, Japan
    - Teva Investigational Site 84072
  - Kagoshima, Japan, 892-0844
    - Teva Investigational Site 84066
  - Kagoshima-shi, Japan
    - Teva Investigational Site 84066
  - Kai, Japan, 400-0124
    - Teva Investigational Site 84069
  - Kai-shi, Japan
    - Teva Investigational Site 84069
  - Kawasaki, Japan, 211-8588
    - Teva Investigational Site 84073
  - Kawasaki-shi, Japan
    - Teva Investigational Site 84073
  - Kyoto, Japan, 600-8811
    - Teva Investigational Site 84067
  - Kyoto, Japan
    - Teva Investigational Site 84067
  - Osaka-shi, Japan, 556-0015
    - Teva Investigational Site 84062
  - Osaka-shi, Japan
    - Teva Investigational Site 84062
  - Saitama, Japan, 338-8577
    - Teva Investigational Site 84070
  - Saitama-shi, Japan
    - Teva Investigational Site 84070
  - Sendai-shi, Japan, 982-0014
    - Teva Investigational Site 84061
  - Sendai-shi, Japan
    - Teva Investigational Site 84061
  - Shimotsuma, Japan
    - Teva Investigational Site 84065
  - Shizuoka, Japan, 4200-853
    - Teva Investigational Site 84068
  - Shizuoka-shi, Japan
    - Teva Investigational Site 84068
  - Tochigi, Japan, 321-0293
    - Teva Investigational Site 84065
  - Tokyo, Japan, 182-0006
    - Teva Investigational Site 84064
  - Toyonaka, Japan
    - Teva Investigational Site 84071
  - Toyonaka-shi, Japan
    - Teva Investigational Site 84071
Poland
- - Krakow, Poland, 31-523
    - Teva Investigational Site 53364
  - Krakow, Poland, 33-332
    - Teva Investigational Site 53363
  - Krakow, Poland
    - Teva Investigational Site 53363
  - Krakow, Poland
    - Teva Investigational Site 53364
  - Lublin, Poland, 20-022
    - Teva Investigational Site 53366
  - Lublin, Poland
    - Teva Investigational Site 53366
  - Poznan, Poland, 60-529
    - Teva Investigational Site 53365
  - Poznan, Poland
    - Teva Investigational Site 53365
  - Warsaw, Poland, 04-730
    - Teva Investigational Site 53367
  - Warsaw, Poland
    - Teva Investigational Site 53367
Russian Federation
- - Kazan, Russian Federation, 420012
    - Teva Investigational Site 50399
  - Kazan, Russian Federation, 420021
    - Teva Investigational Site 50395
  - Kazan, Russian Federation
    - Teva Investigational Site 50395
  - Kazan, Russian Federation
    - Teva Investigational Site 50399
  - Moscow, Russian Federation, 121467
    - Teva Investigational Site 50394
  - Moscow, Russian Federation, 129128
    - Teva Investigational Site 50400
  - Moscow, Russian Federation
    - Teva Investigational Site 50394
  - Moscow, Russian Federation
    - Teva Investigational Site 50400
  - Nizhniy Novgorod, Russian Federation, 603126
    - Teva Investigational Site 50398
  - Nizhniy Novgorod, Russian Federation, 603137
    - Teva Investigational Site 50396
  - Nizhniy Novgorod, Russian Federation
    - Teva Investigational Site 50396
  - Nizhniy Novgorod, Russian Federation
    - Teva Investigational Site 50398
  - Ufa, Russian Federation, 450007
    - Teva Investigational Site 50397
  - Ufa, Russian Federation
    - Teva Investigational Site 50397
Spain
- - Madrid, Spain, 28046
    - Teva Investigational Site 31207
  - Madrid, Spain
    - Teva Investigational Site 31207
  - Pamplona, Spain, 31008
    - Teva Investigational Site 31208
  - Pamplona, Spain
    - Teva Investigational Site 31208
  - Valladolid, Spain, 47003
    - Teva Investigational Site 31205
  - Valladolid, Spain
    - Teva Investigational Site 31205
  - Zaragoza, Spain, 50009
    - Teva Investigational Site 31206
  - Zaragoza, Spain
    - Teva Investigational Site 31206
United States
- Alabama
  - Birmingham, Alabama, United States, 35211
    - Teva Investigational Site 13628
  - Birmingham, Alabama, United States, 35216
    - Teva Investigational Site 13577
  - Birmingham, Alabama, United States
    - Teva Investigational Site 13577
  - Birmingham, Alabama, United States
    - Teva Investigational Site 13628
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Teva Investigational Site 13606
  - Phoenix, Arizona, United States, 85023
    - Teva Investigational Site 13579
  - Phoenix, Arizona, United States
    - Teva Investigational Site 13579
  - Phoenix, Arizona, United States
    - Teva Investigational Site 13606
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Teva Investigational Site 13602
  - Little Rock, Arkansas, United States
    - Teva Investigational Site 13602
- California
  - Encino, California, United States, 91316
    - Teva Investigational Site 13568
  - Encino, California, United States
    - Teva Investigational Site 13568
  - Fullerton, California, United States, 92835
    - Teva Investigational Site 13546
  - Fullerton, California, United States
    - Teva Investigational Site 13546
  - Long Beach, California, United States, 90806
    - Teva Investigational Site 13540
  - Long Beach, California, United States
    - Teva Investigational Site 13540
  - Redlands, California, United States, 92374
    - Teva Investigational Site 13632
  - Redlands, California, United States
    - Teva Investigational Site 13632
  - Redondo Beach, California, United States, 90277
    - Teva Investigational Site 13571
  - Redondo Beach, California, United States
    - Teva Investigational Site 13571
  - San Diego, California, United States, 92103
    - Teva Investigational Site 13573
  - San Diego, California, United States
    - Teva Investigational Site 13573
  - Santa Monica, California, United States, 90404
    - Teva Investigational Site 13538
  - Santa Monica, California, United States
    - Teva Investigational Site 13538
  - Santa Rosa, California, United States, 95405
    - Teva Investigational Site 13594
  - Santa Rosa, California, United States
    - Teva Investigational Site 13594
  - Walnut Creek, California, United States, 94598
    - Teva Investigational Site 13595
  - Walnut Creek, California, United States
    - Teva Investigational Site 13595
- Colorado
  - Aurora, Colorado, United States, 80014
    - Teva Investigational Site 13629
  - Aurora, Colorado, United States
    - Teva Investigational Site 13629
  - Boulder, Colorado, United States, 80301
    - Teva Investigational Site 13557
  - Boulder, Colorado, United States
    - Teva Investigational Site 13557
  - Colorado Springs, Colorado, United States, 80918
    - Teva Investigational Site 13593
  - Colorado Springs, Colorado, United States
    - Teva Investigational Site 13593
  - Denver, Colorado, United States, 80210
    - Teva Investigational Site 13633
  - Denver, Colorado, United States, 80239
    - Teva Investigational Site 13612
  - Denver, Colorado, United States
    - Teva Investigational Site 13612
  - Denver, Colorado, United States
    - Teva Investigational Site 13633
  - Englewood, Colorado, United States, 80113
    - Teva Investigational Site 13631
  - Englewood, Colorado, United States
    - Teva Investigational Site 13631
- Connecticut
  - East Hartford, Connecticut, United States, 06118
    - Teva Investigational Site 13563
  - East Hartford, Connecticut, United States
    - Teva Investigational Site 13563
  - Stamford, Connecticut, United States, 06905
    - Teva Investigational Site 13550
  - Stamford, Connecticut, United States
    - Teva Investigational Site 13550
- Florida
  - Bradenton, Florida, United States, 34201
    - Teva Investigational Site 13635
  - Bradenton, Florida, United States
    - Teva Investigational Site 13635
  - Gainesville, Florida, United States, 32607
    - Teva Investigational Site 13597
  - Gainesville, Florida, United States
    - Teva Investigational Site 13597
  - Hialeah, Florida, United States, 33012
    - Teva Investigational Site 13607
  - Hialeah, Florida, United States
    - Teva Investigational Site 13607
  - Jacksonville, Florida, United States, 32205
    - Teva Investigational Site 13559
  - Jacksonville, Florida, United States
    - Teva Investigational Site 13559
  - Ocala, Florida, United States, 34471
    - Teva Investigational Site 13584
  - Ocala, Florida, United States
    - Teva Investigational Site 13584
  - Orlando, Florida, United States, 32806
    - Teva Investigational Site 13587
  - Orlando, Florida, United States, 32819
    - Teva Investigational Site 13599
  - Orlando, Florida, United States
    - Teva Investigational Site 13551
  - Orlando, Florida, United States
    - Teva Investigational Site 13555
  - Orlando, Florida, United States
    - Teva Investigational Site 13587
  - Orlando, Florida, United States
    - Teva Investigational Site 13599
  - Palm Beach Gardens, Florida, United States, 33410
    - Teva Investigational Site 13567
  - Palm Beach Gardens, Florida, United States
    - Teva Investigational Site 13567
  - Pembroke Pines, Florida, United States, 33026
    - Teva Investigational Site 13553
  - Pembroke Pines, Florida, United States
    - Teva Investigational Site 13553
  - Pinellas Park, Florida, United States, 33781
    - Teva Investigational Site 13616
  - Pinellas Park, Florida, United States
    - Teva Investigational Site 13616
- Georgia
  - Atlanta, Georgia, United States, 30312
    - Teva Investigational Site 13620
  - Atlanta, Georgia, United States, 30342
    - Teva Investigational Site 13537
  - Atlanta, Georgia, United States
    - Teva Investigational Site 13537
  - Atlanta, Georgia, United States
    - Teva Investigational Site 13620
- Idaho
  - Boise, Idaho, United States
    - Teva Investigational Site 13604
  - Meridian, Idaho, United States, 83642
    - Teva Investigational Site 13604
- Illinois
  - Chicago, Illinois, United States, 60607
    - Teva Investigational Site 13585
  - Chicago, Illinois, United States, 60654
    - Teva Investigational Site 13621
  - Chicago, Illinois, United States
    - Teva Investigational Site 13585
  - Chicago, Illinois, United States
    - Teva Investigational Site 13621
  - Evanston, Illinois, United States, 60201
    - Teva Investigational Site 13627
  - Evanston, Illinois, United States
    - Teva Investigational Site 13627
- Indiana
  - Indianapolis, Indiana, United States, 46254
    - Teva Investigational Site 13596
  - Indianapolis, Indiana, United States
    - Teva Investigational Site 13596
- Kansas
  - Wichita, Kansas, United States, 67207
    - Teva Investigational Site 13617
  - Wichita, Kansas, United States, 67211
    - Teva Investigational Site 13598
  - Wichita, Kansas, United States
    - Teva Investigational Site 13598
  - Wichita, Kansas, United States
    - Teva Investigational Site 13617
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Teva Investigational Site 13566
  - Louisville, Kentucky, United States
    - Teva Investigational Site 13566
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Teva Investigational Site 13603
  - Metairie, Louisiana, United States
    - Teva Investigational Site 13603
- Maryland
  - Baltimore, Maryland, United States
    - Teva Investigational Site 13582
  - Pikesville, Maryland, United States, 21208
    - Teva Investigational Site 13582
- Massachusetts
  - Boston, Massachusetts, United States, 02131
    - Teva Investigational Site 13590
  - Boston, Massachusetts, United States
    - Teva Investigational Site 13590
  - New Bedford, Massachusetts, United States, 02301
    - Teva Investigational Site 13589
  - New Bedford, Massachusetts, United States
    - Teva Investigational Site 13589
  - Watertown, Massachusetts, United States, 02472
    - Teva Investigational Site 13543
  - Watertown, Massachusetts, United States
    - Teva Investigational Site 13543
- Michigan
  - Ann Arbor, Michigan, United States, 48104
    - Teva Investigational Site 13539
  - Ann Arbor, Michigan, United States
    - Teva Investigational Site 13539
- Minnesota
  - Golden Valley, Minnesota, United States, 55422
    - Teva Investigational Site 13542
  - Golden Valley, Minnesota, United States
    - Teva Investigational Site 13542
- Missouri
  - Kansas City, Missouri, United States, 64114
    - Teva Investigational Site 13534
  - Kansas City, Missouri, United States
    - Teva Investigational Site 13534
  - Saint Louis, Missouri, United States, 63141
    - Teva Investigational Site 13619
  - Saint Louis, Missouri, United States
    - Teva Investigational Site 13619
  - Springfield, Missouri, United States
    - Teva Investigational Site 13536
- Nebraska
  - Fremont, Nebraska, United States, 68025
    - Teva Investigational Site 13618
  - Fremont, Nebraska, United States
    - Teva Investigational Site 13618
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Teva Investigational Site 13605
  - Las Vegas, Nevada, United States
    - Teva Investigational Site 13605
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Teva Investigational Site 13578
  - Lebanon, New Hampshire, United States
    - Teva Investigational Site 13578
- New Jersey
  - Martinsville, New Jersey, United States
    - Teva Investigational Site 13575
  - Raritan, New Jersey, United States, 08869
    - Teva Investigational Site 13575
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Teva Investigational Site 13588
  - Albuquerque, New Mexico, United States
    - Teva Investigational Site 13588
- New York
  - Amherst, New York, United States, 14226
    - Teva Investigational Site 13576
  - Amherst, New York, United States
    - Teva Investigational Site 13576
  - Plainview, New York, United States, 11803
    - Teva Investigational Site 13565
  - Plainview, New York, United States
    - Teva Investigational Site 13565
- North Carolina
  - Greensboro, North Carolina, United States, 27401
    - Teva Investigational Site 13544
  - Greensboro, North Carolina, United States, 27408
    - Teva Investigational Site 13574
  - Greensboro, North Carolina, United States
    - Teva Investigational Site 13544
  - Greensboro, North Carolina, United States
    - Teva Investigational Site 13574
  - Raleigh, North Carolina, United States, 27607
    - Teva Investigational Site 13545
  - Raleigh, North Carolina, United States
    - Teva Investigational Site 13545
- Ohio
  - Akron, Ohio, United States, 44311
    - Teva Investigational Site 13609
  - Akron, Ohio, United States, 44311
    - Teva Investigational Site 13634
  - Akron, Ohio, United States
    - Teva Investigational Site 13609
  - Akron, Ohio, United States
    - Teva Investigational Site 13634
  - Cincinnati, Ohio, United States, 45227
    - Teva Investigational Site 13533
  - Cincinnati, Ohio, United States, 45249
    - Teva Investigational Site 13624
  - Cincinnati, Ohio, United States
    - Teva Investigational Site 13533
  - Cincinnati, Ohio, United States
    - Teva Investigational Site 13624
  - Cleveland, Ohio, United States, 44195
    - Teva Investigational Site 13569
  - Cleveland, Ohio, United States
    - Teva Investigational Site 13569
  - Columbus, Ohio, United States, 43212
    - Teva Investigational Site 13626
  - Columbus, Ohio, United States
    - Teva Investigational Site 13626
  - Mogadore, Ohio, United States, 44260
    - Teva Investigational Site 13625
  - Mogadore, Ohio, United States
    - Teva Investigational Site 13625
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Teva Investigational Site 13561
  - Oklahoma City, Oklahoma, United States
    - Teva Investigational Site 13561
- Oregon
  - Eugene, Oregon, United States, 97401
    - Teva Investigational Site 13601
  - Eugene, Oregon, United States
    - Teva Investigational Site 13601
- Pennsylvania
  - Jenkintown, Pennsylvania, United States, 19046
    - Teva Investigational Site 13591
  - Jenkintown, Pennsylvania, United States
    - Teva Investigational Site 13591
  - Philadelphia, Pennsylvania, United States, 19107
    - Teva Investigational Site 13554
  - Philadelphia, Pennsylvania, United States
    - Teva Investigational Site 13554
  - Uniontown, Pennsylvania, United States, 15401
    - Teva Investigational Site 13608
  - Uniontown, Pennsylvania, United States
    - Teva Investigational Site 13608
- South Carolina
  - Greer, South Carolina, United States, 29650
    - Teva Investigational Site 13615
  - Greer, South Carolina, United States
    - Teva Investigational Site 13615
  - Mount Pleasant, South Carolina, United States, 29464
    - Teva Investigational Site 13556
  - Mount Pleasant, South Carolina, United States
    - Teva Investigational Site 13556
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Teva Investigational Site 13560
  - Bristol, Tennessee, United States
    - Teva Investigational Site 13560
  - Nashville, Tennessee, United States, 37203
    - Teva Investigational Site 13532
  - Nashville, Tennessee, United States, 37203
    - Teva Investigational Site 13552
  - Nashville, Tennessee, United States
    - Teva Investigational Site 13532
  - Nashville, Tennessee, United States
    - Teva Investigational Site 13552
- Texas
  - Austin, Texas, United States, 78731
    - Teva Investigational Site 13541
  - Austin, Texas, United States
    - Teva Investigational Site 13541
  - Dallas, Texas, United States, 75214
    - Teva Investigational Site 13623
  - Dallas, Texas, United States
    - Teva Investigational Site 13623
  - Plano, Texas, United States, 75024
    - Teva Investigational Site 13611
  - Plano, Texas, United States
    - Teva Investigational Site 13611
  - San Antonio, Texas, United States, 78229
    - Teva Investigational Site 13572
  - San Antonio, Texas, United States
    - Teva Investigational Site 13572
- Utah
  - Murray, Utah, United States, 84107
    - Teva Investigational Site 13614
  - Murray, Utah, United States
    - Teva Investigational Site 13614
  - West Jordan, Utah, United States, 84088
    - Teva Investigational Site 13581
  - West Jordan, Utah, United States
    - Teva Investigational Site 13581
- Virginia
  - Virginia Beach, Virginia, United States, 23454
    - Teva Investigational Site 13630
  - Virginia Beach, Virginia, United States
    - Teva Investigational Site 13630
- Washington
  - Seattle, Washington, United States, 98105
    - Teva Investigational Site 13564
  - Seattle, Washington, United States, 98105
    - Teva Investigational Site 13586
  - Seattle, Washington, United States
    - Teva Investigational Site 13564
  - Seattle, Washington, United States
    - Teva Investigational Site 13586
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Teva Investigational Site 13600
  - Morgantown, West Virginia, United States
    - Teva Investigational Site 13600

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

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
Patient signs and dates the informed consent document
Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
85% e-diary compliance
Total body weight between 99 and 250 lbs, inclusive
- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma
Pregnant or nursing females
History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer
- 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
Masking: QUADRUPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Matching Placebo	Drug: Placebo Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.
EXPERIMENTAL: Fremanezumab 675 mg/placebo/placebo Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.	Drug: Placebo Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site. Drug: Fremanezumab Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site. Other Names: TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)
EXPERIMENTAL: Fremanezumab 675/225/225 mg Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.	Drug: Fremanezumab Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site. Other Names: TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)	Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Participants With Treatment-Emergent Adverse Events (TEAEs) Time Frame: Day 1 to Week 12	An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, 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 the patient and required medical intervention to prevent the previously listed serious outcomes.	Day 1 to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - 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 endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is 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 are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity Time Frame: Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)	Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered non-responders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The percentage reduction in monthly average is calculated as: ((baseline value - post-baseline value) / baseline value) * 100.	Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)
Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)	Participants recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)	Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)
Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)	A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of >= moderate severity was defined as a calendar day where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of >= moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. Change is post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12 Time Frame: Baseline, 12 weeks	The HIT-6 was developed by Kosinski et al (2003) as a short form for reliably assessing the adverse headache impact in clinical practice and clinical research settings. The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. Scores range from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the patient, i.e. scores ≤49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact; and scores ≥60 indicate severe impact. Negative change from baseline values indicate less adverse impact of headache.	Baseline, 12 weeks
Electrocardiogram (ECG) Findings Shifts From Baseline to Overall Time Frame: Baseline (Day 0), Treatment Week 12 (or endpoint)	12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the participant is summarized. Only participants with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant. - CS= abnormal, clinically significant. Shift format is: baseline finding / worst post-baseline finding.	Baseline (Day 0), Treatment Week 12 (or endpoint)
Participants With Vital Signs Potentially Clinically Significant Abnormal Values Time Frame: Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0.	Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with potentially clinically significant abnormal findings included: - Pulse Rate High: >=120 and increase of >=15 beats per minute - Pulse Rate Low: <=50 and decrease of >=15 beats per minute - Systolic Blood Pressure Low: <=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure High: >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure Low: <=50 mmHg and decrease of >=15 mmHg - Respiratory Rate Low: <10 breaths / minute	Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0.
Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results Time Frame: Treatment Days 28, 56 and 84 (or endpoint)	Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: >=10.71 mmol/L - Creatinine High: >=177 umol/L - Bilirubin High: >=34.2 umol/L - Alanine Aminotransferase (ALT): >=3upper limit of normal (ULN) - Aspartate Aminotransferase (AST): >=3upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): >=3upper limit of normal (ULN) - Hemoglobin: Male: <115 g/L or Female: <=95 g/L - Hematocrit: Male: <0.37 L/L or Female: <0.32 L/L - Leukocytes: >=2010^9/L or <=310^9/L - Eosinophils/Leukocytes: >=10% - Platelets: >=70010^9/L or <=75*10^9/L	Treatment Days 28, 56 and 84 (or endpoint)
Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results Time Frame: Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0.	Urinalysis with potentially clinically significant abnormal findings included: - Blood: >=2 unit increase from baseline - Urine Glucose (mg/dL): >=2 unit increase from baseline - Ketones (mg/dL): >=2 unit increase from baseline - Urine Protein (mg/dL): >=2 unit increase from baseline	Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0.
Prothrombin Time Shifts From Baseline to Endpoint Time Frame: Baseline (Day 0), Treatment Endpoint (Week 12)	Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding	Baseline (Day 0), Treatment Endpoint (Week 12)
Injection Site Reaction Adverse Events Time Frame: Day 1 to Week 12	Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.	Day 1 to Week 12
Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug Time Frame: Baseline (Day 0), Treatment Days 28, 56, 84	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the participant's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. The eC-SSRS Baseline/Screening version was completed by the participant at baseline, and the eC-SSRS Since Last Visit version was completed by the participant at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized.	Baseline (Day 0), Treatment Days 28, 56, 84

Collaborators and Investigators

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

Sponsor

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)

March 22, 2016

Primary Completion (ACTUAL)

April 11, 2017

Study Completion (ACTUAL)

April 11, 2017

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (ESTIMATE)

December 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

TV48125-CNS-30049
2015-004549-23 (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

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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Secondary Outcome Measures

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Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Placebo

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