Assessment of LBR-101 In Chronic Migraine

December 7, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine

The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be compared to placebo for safety and efficacy. The mean change from baseline in the number of cumulative headache hours measured at the 28-day period ending with week 12.

Study Type

Interventional

Enrollment (Actual)

264

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
    • 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
      • 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
    • 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
      • 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
    • 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.
  • Chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013)
  • 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 headache data on a minimum of 22/28 days (80% diary compliance)

Exclusion Criteria:

  • Onset of chronic migraine after the age of 50 years.
  • 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 6 months prior to study entry.
  • Subject is using 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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 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 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
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
Mean Change From Baseline in the Number of Monthly Cumulative Headache Hours of Any Severity on Headache Days Relative to the 28-day Post-treatment Period Ending With Week 12
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 hours with headache of any severity 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in the Number of Headache Days of at Least Moderate Severity Relative to the 28-day Post-treatment Period Ending With Week 12
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 of at least moderate severity 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.

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)

February 28, 2015

Study Completion (Actual)

March 31, 2015

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBR-101-021

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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