A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
- Conditions
- Episodic Migraine Headache
- Interventions
- Drug: LBR-101 High DoseDrug: PlaceboDrug: LBR-101 Low Dose
- Registration Number
- NCT02025556
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 297
-
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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 LBR-101 Low Dose LBR-101 Low Dose Subcutaneous Low Dose LBR-101 Administered Monthly x 3
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With Week 12 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.
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.
Number of Participants Reporting Mild, Moderate, and Severe Adverse Events (AEs) 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
- Secondary Outcome Measures
Name Time Method Change From Baseline in Number of Days With Headache of Any Severity 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.
Trial Locations
- Locations (63)
Teva Investigational Site 135
🇺🇸Brockton, Massachusetts, United States
Teva Investigational Site 124
🇺🇸New Bedford, Massachusetts, United States
Teva Investigational Site 109
🇺🇸Watertown, Massachusetts, United States
Teva Investigational Site 114
🇺🇸Kalamazoo, Michigan, United States
Teva Investigational Site 107
🇺🇸Springfield, Missouri, United States
Teva Investigational Site 104
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 148
🇺🇸Reno, Nevada, United States
Teva Investigational Site 131
🇺🇸Greensboro, North Carolina, United States
Teva Investigational Site 165
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 118
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 115
🇺🇸Worcester, Massachusetts, United States
Teva Investigational Site 162
🇺🇸Stamford, Connecticut, United States
Teva Investigational Site 117
🇺🇸Scottsdale, Arizona, United States
Teva Investigational Site 153
🇺🇸Bristol, Tennessee, United States
Teva Investigational Site 149
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 102
🇺🇸Columbus, Ohio, United States
Teva Investigational Site 122
🇺🇸Canton, Ohio, United States
Teva Investigational Site 155
🇺🇸Cleveland, Ohio, United States
Teva Investigational Site 111
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 130
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 113
🇺🇸San Francisco, California, United States
Teva Investigational Site 127
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 154
🇺🇸Nashville, Tennessee, United States
Teva Investigational Site 157
🇺🇸Salt Lake City, Utah, United States
Teva Investigational Site 145
🇺🇸Gilbert, Arizona, United States
Teva Investigational Site 158
🇺🇸Little Rock, Arkansas, United States
Teva Investigational Site 126
🇺🇸Memphis, Tennessee, United States
Teva Investigational Site 123
🇺🇸Charlottesville, Virginia, United States
Teva Investigational Site 134
🇺🇸Douglasville, Georgia, United States
Teva Investigational Site 151
🇺🇸Springfield, Massachusetts, United States
Teva Investigational Site 125
🇺🇸Evansville, Indiana, United States
Teva Investigational Site 144
🇺🇸Roanoke, Virginia, United States
Teva Investigational Site 141
🇺🇸Cincinnati, Ohio, United States
Teva Investigational Site 142
🇺🇸Cincinnati, Ohio, United States
Teva Investigational Site 156
🇺🇸Mansfield, Texas, United States
Teva Investigational Site 128
🇺🇸Arlington, Texas, United States
Teva Investigational Site 150
🇺🇸Golden Valley, Minnesota, United States
Teva Investigational Site 132
🇺🇸Boulder, Colorado, United States
Teva Investigational Site 161
🇺🇸Anaheim, California, United States
Teva Investigational Site 119
🇺🇸Long Beach, California, United States
Teva Investigational Site 146
🇺🇸Oceanside, California, United States
Teva Investigational Site 108
🇺🇸Stanford, California, United States
Teva Investigational Site 116
🇺🇸Fullerton, California, United States
Teva Investigational Site 112
🇺🇸Walnut Creek, California, United States
Teva Investigational Site 143
🇺🇸DeLand, Florida, United States
Teva Investigational Site 101
🇺🇸Jacksonville, Florida, United States
Teva Investigational Site 166
🇺🇸Jacksonville, Florida, United States
Teva Investigational Site 137
🇺🇸Hialeah, Florida, United States
Teva Investigational Site 159
🇺🇸Hollywood, Florida, United States
Teva Investigational Site 164
🇺🇸Decatur, Georgia, United States
Teva Investigational Site 129
🇺🇸Maitland, Florida, United States
Teva Investigational Site 139
🇺🇸Ormond Beach, Florida, United States
Teva Investigational Site 160
🇺🇸South Miami, Florida, United States
Teva Investigational Site 140
🇺🇸Port Orange, Florida, United States
Teva Investigational Site 133
🇺🇸Lenexa, Kansas, United States
Teva Investigational Site 110
🇺🇸Ann Arbor, Michigan, United States
Teva Investigational Site 167
🇺🇸Orlando, Florida, United States
Teva Investigational Site 152
🇺🇸Kansas City, Missouri, United States
Teva Investigational Site 168
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 105
🇺🇸Bronx, New York, United States
Teva Investigational Site 121
🇺🇸Austin, Texas, United States
Teva Investigational Site 136
🇺🇸Austin, Texas, United States
Teva Investigational Site 120
🇺🇸Goose Creek, South Carolina, United States