Assessment of LBR-101 In Chronic Migraine

Phase 2

Completed

Conditions: Chronic Migraine

Interventions: Drug: LBR-101 Low Dose
Drug: LBR-101 High Dose
Drug: Placebo

Registration Number: NCT02021773

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 264

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBR-101 Low Dose	LBR-101 Low Dose	Subcutaneous Low Dose LBR-101 Administered Monthly x 3
LBR-101 High Dose	LBR-101 High Dose	Subcutaneous High Dose LBR-101 Administered Monthly x 3
Placebo	Placebo	Subcutaneous Placebo Administered Monthly x 3

Primary Outcome Measures

Name	Time	Method
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	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.
Number of Participants With at Least One Adverse Event	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (57): Teva Investigational Site 161
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Anaheim, California, United States
Teva Investigational Site 116
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Fullerton, California, United States
Teva Investigational Site 108
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Stanford, California, United States
Teva Investigational Site 101
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Jacksonville, Florida, United States
Teva Investigational Site 149
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Atlanta, Georgia, United States
Teva Investigational Site 139
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Ormond Beach, Florida, United States
Teva Investigational Site 125
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Evansville, Indiana, United States
Teva Investigational Site 107
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Springfield, Missouri, United States
Teva Investigational Site 150
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Golden Valley, Minnesota, United States
Teva Investigational Site 109
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Watertown, Massachusetts, United States
Teva Investigational Site 115
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Worcester, Massachusetts, United States
Teva Investigational Site 151
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Springfield, Massachusetts, United States
Teva Investigational Site 148
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Reno, Nevada, United States
Teva Investigational Site 130
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Phoenix, Arizona, United States
Teva Investigational Site 142
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Cincinnati, Ohio, United States
Teva Investigational Site 119
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Long Beach, California, United States
Teva Investigational Site 145
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Gilbert, Arizona, United States
Teva Investigational Site 137
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Hialeah, Florida, United States
Teva Investigational Site 135
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Brockton, Massachusetts, United States
Teva Investigational Site 164
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Decatur, Georgia, United States
Teva Investigational Site 113
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San Francisco, California, United States
Teva Investigational Site 141
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Cincinnati, Ohio, United States
Teva Investigational Site 129
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Maitland, Florida, United States
Teva Investigational Site 143
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DeLand, Florida, United States
Teva Investigational Site 117
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Scottsdale, Arizona, United States
Teva Investigational Site 166
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Jacksonville, Florida, United States
Teva Investigational Site 112
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Walnut Creek, California, United States
Teva Investigational Site 146
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Oceanside, California, United States
Teva Investigational Site 134
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Douglasville, Georgia, United States
Teva Investigational Site 133
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Lenexa, Kansas, United States
Teva Investigational Site 162
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Stamford, Connecticut, United States
Teva Investigational Site 155
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Cleveland, Ohio, United States
Teva Investigational Site 124
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New Bedford, Massachusetts, United States
Teva Investigational Site 104
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Saint Louis, Missouri, United States
Teva Investigational Site 114
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Kalamazoo, Michigan, United States
Teva Investigational Site 118
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Raleigh, North Carolina, United States
Teva Investigational Site 131
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Greensboro, North Carolina, United States
Teva Investigational Site 122
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Canton, Ohio, United States
Teva Investigational Site 153
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Bristol, Tennessee, United States
Teva Investigational Site 102
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Columbus, Ohio, United States
Teva Investigational Site 126
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Memphis, Tennessee, United States
Teva Investigational Site 144
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Roanoke, Virginia, United States
Teva Investigational Site 120
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Goose Creek, South Carolina, United States
Teva Investigational Site 123
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Charlottesville, Virginia, United States
Teva Investigational Site 154
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Nashville, Tennessee, United States
Teva Investigational Site 127
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Oklahoma City, Oklahoma, United States
Teva Investigational Site 132
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Boulder, Colorado, United States
Teva Investigational Site 140
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Port Orange, Florida, United States
Teva Investigational Site 111
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Philadelphia, Pennsylvania, United States
Teva Investigational Site 128
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Arlington, Texas, United States
Teva Investigational Site 167
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Orlando, Florida, United States
Teva Investigational Site 110
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Ann Arbor, Michigan, United States
Teva Investigational Site 152
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Kansas City, Missouri, United States
Teva Investigational Site 105
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Bronx, New York, United States
Teva Investigational Site 121
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Austin, Texas, United States
Teva Investigational Site 136
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Austin, Texas, United States
Teva Investigational Site 168
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Winston-Salem, North Carolina, United States