A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine

January 18, 2022 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 Two Doses of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of High Frequency Episodic Migraine

The purpose of this study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in subjects with high frequency episodic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Teva Investigational Site 145
      • Phoenix, Arizona, United States, 85032
        • Teva Investigational Site 130
      • Scottsdale, Arizona, United States, 85259
        • Teva Investigational Site 117
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Teva Investigational Site 158
    • California
      • Anaheim, California, United States, 92801
        • Teva Investigational Site 161
      • Fullerton, California, United States, 92835
        • Teva Investigational Site 116
      • Long Beach, California, United States, 90806
        • Teva Investigational Site 119
      • Oceanside, California, United States, 92056
        • Teva Investigational Site 146
      • San Francisco, California, United States, 94109
        • Teva Investigational Site 113
      • Stanford, California, United States, 94305
        • Teva Investigational Site 108
      • Walnut Creek, California, United States, 94598
        • Teva Investigational Site 112
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Teva Investigational Site 132
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Teva Investigational Site 162
    • Florida
      • DeLand, Florida, United States, 32720
        • Teva Investigational Site 143
      • Hialeah, Florida, United States, 33012
        • Teva Investigational Site 137
      • Hollywood, Florida, United States, 33024
        • Teva Investigational Site 159
      • Jacksonville, Florida, United States, 32216
        • Teva Investigational Site 101
      • Jacksonville, Florida, United States, 32256
        • Teva Investigational Site 166
      • Maitland, Florida, United States, 32751
        • Teva Investigational Site 129
      • Orlando, Florida, United States, 32801
        • Teva Investigational Site 167
      • Ormond Beach, Florida, United States, 32174
        • Teva Investigational Site 139
      • Port Orange, Florida, United States, 32127
        • Teva Investigational Site 140
      • South Miami, Florida, United States, 33143
        • Teva Investigational Site 160
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Teva Investigational Site 149
      • Decatur, Georgia, United States, 30030
        • Teva Investigational Site 164
      • Douglasville, Georgia, United States, 30134
        • Teva Investigational Site 134
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Teva Investigational Site 125
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • Teva Investigational Site 133
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Teva Investigational Site 135
      • New Bedford, Massachusetts, United States, 02740
        • Teva Investigational Site 124
      • Springfield, Massachusetts, United States, 01104
        • Teva Investigational Site 151
      • Watertown, Massachusetts, United States, 02472
        • Teva Investigational Site 109
      • Worcester, Massachusetts, United States, 01605
        • Teva Investigational Site 115
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Teva Investigational Site 110
      • Kalamazoo, Michigan, United States, 49009
        • Teva Investigational Site 114
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Teva Investigational Site 150
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Teva Investigational Site 152
      • Saint Louis, Missouri, United States, 63141
        • Teva Investigational Site 104
      • Springfield, Missouri, United States, 65807
        • Teva Investigational Site 107
    • Nevada
      • Reno, Nevada, United States, 89502
        • Teva Investigational Site 148
    • New York
      • Bronx, New York, United States, 10461
        • Teva Investigational Site 105
    • North Carolina
      • Greensboro, North Carolina, United States, 27405-6962
        • Teva Investigational Site 131
      • Raleigh, North Carolina, United States, 27607
        • Teva Investigational Site 118
      • Raleigh, North Carolina, United States, 27612
        • Teva Investigational Site 165
      • Winston-Salem, North Carolina, United States, 27103
        • Teva Investigational Site 168
    • Ohio
      • Canton, Ohio, United States, 44718
        • Teva Investigational Site 122
      • Cincinnati, Ohio, United States, 45227
        • Teva Investigational Site 141
      • Cincinnati, Ohio, United States, 45229-3039
        • Teva Investigational Site 142
      • Cleveland, Ohio, United States, 44195
        • Teva Investigational Site 155
      • Columbus, Ohio, United States, 43221
        • Teva Investigational Site 102
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Teva Investigational Site 127
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Teva Investigational Site 111
    • South Carolina
      • Goose Creek, South Carolina, United States, 29445
        • Teva Investigational Site 120
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Teva Investigational Site 153
      • Memphis, Tennessee, United States, 38119
        • Teva Investigational Site 126
      • Nashville, Tennessee, United States, 37203
        • Teva Investigational Site 154
    • Texas
      • Arlington, Texas, United States, 76012
        • Teva Investigational Site 128
      • Austin, Texas, United States, 78731
        • Teva Investigational Site 121
      • Austin, Texas, United States, 78745
        • Teva Investigational Site 136
      • Mansfield, Texas, United States, 76063
        • Teva Investigational Site 156
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Teva Investigational Site 157
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Teva Investigational Site 123
      • Roanoke, Virginia, United States, 24018
        • Teva Investigational Site 144

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females aged 18 to 65 years of age.
  • A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.

  • Subjects fulfilling criteria for episodic migraine as per the Second Edition of The International Headache Society (Olesen and Steiner 2004), who experience migraine at high frequency as follows:

    i. History of headaches on more than 8 days per month for at least 3 months prior to screening

ii. Verification of headache frequency through prospectively collected baseline information during the 28-day run-in phase demonstrating headaches (of any type) on at least 8 days with at total of 8 to 14 days* fulfilling criteria for migraine.

*Operational definition for migraine and probable migraine days are presented in the statistical section of this protocol.

  • Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg, inclusive.
  • Demonstrated compliance with the electronic headache diary during the run-in period by entry of headache data on a minimum of 22/28 days (80% compliance).

Exclusion Criteria:

  • Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the six months prior to screening.
  • Subject uses medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason.
  • Failed > 2 medication categories or > 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial
  • Treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the CGRP pathway.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LBR-101 High Dose
Subcutaneous High Dose LBR-101 Administered Monthly x 3
Drug: LBR-101 High Dose
Subcutaneously Administered High Dose LBR-101 Monthly x 3
Other Names:
  • Fremanezumab
EXPERIMENTAL: LBR-101 Low Dose
Subcutaneous Low Dose LBR-101 Administered Monthly x 3
Drug: LBR-101 Low Dose
Subcutaneously Administered Low Dose LBR-101 Monthly x 3
Other Names:
  • Fremanezumab
PLACEBO_COMPARATOR: Placebo
Subcutaneous Placebo Administered Monthly x 3
Drug: Placebo
Subcutaneously Administered Placebo (Vehicle) Monthly x 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With Week 12
Time Frame: Baseline to week 12
A migraine day was endorsed when at least 1 of the following situations occurred: 1) A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine, or 2) 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 one migraine criterion is missing, or 3) the participant used acute migraine medication (triptans and ergot compounds) to treat a headache of any duration, or 4) any of the above days preceded or followed by a day with a headache of any duration. This calculation was defined as the change from baseline in the number of headache days during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.
Baseline to week 12
Number of Participants With at Least One Adverse Event
Time Frame: Baseline to week 12
An 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. 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 participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline to week 12
Number of Participants Reporting Mild, Moderate, and Severe Adverse Events (AEs)
Time Frame: Up to week 12
Adverse events were rated based on the investigator's clinical judgment. Mild: awareness of a sign or symptom that was easily tolerated Moderate: sign or symptom intense enough to interfere with usual activity Severe: interfered significantly with ability to do work or usual activity
Up to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Number of Days With Headache of Any Severity
Time Frame: Baseline to week 12
A headache 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 of any severity or the participant used acute migraine medication (triptans and ergot compounds) to treat a headache. This calculation was defined as the change from baseline in the number of headache days during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.
Baseline to week 12

Collaborators and Investigators

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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

NCGS, 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)

January 31, 2014

Primary Completion (ACTUAL)

January 31, 2015

Study Completion (ACTUAL)

March 31, 2015

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (ESTIMATE)

January 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBR-101-022

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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