Episodic Migraine Headache Clinical Trial
Official title:
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
| Verified date | January 2022 |
| Source | Teva Branded Pharmaceutical Products R&D, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 297 |
| Est. completion date | March 31, 2015 |
| Est. primary completion date | January 31, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Teva Investigational Site 161 | Anaheim | California |
| United States | Teva Investigational Site 110 | Ann Arbor | Michigan |
| United States | Teva Investigational Site 128 | Arlington | Texas |
| United States | Teva Investigational Site 149 | Atlanta | Georgia |
| United States | Teva Investigational Site 121 | Austin | Texas |
| United States | Teva Investigational Site 136 | Austin | Texas |
| United States | Teva Investigational Site 132 | Boulder | Colorado |
| United States | Teva Investigational Site 153 | Bristol | Tennessee |
| United States | Teva Investigational Site 135 | Brockton | Massachusetts |
| United States | Teva Investigational Site 105 | Bronx | New York |
| United States | Teva Investigational Site 122 | Canton | Ohio |
| United States | Teva Investigational Site 123 | Charlottesville | Virginia |
| United States | Teva Investigational Site 141 | Cincinnati | Ohio |
| United States | Teva Investigational Site 142 | Cincinnati | Ohio |
| United States | Teva Investigational Site 155 | Cleveland | Ohio |
| United States | Teva Investigational Site 102 | Columbus | Ohio |
| United States | Teva Investigational Site 164 | Decatur | Georgia |
| United States | Teva Investigational Site 143 | DeLand | Florida |
| United States | Teva Investigational Site 134 | Douglasville | Georgia |
| United States | Teva Investigational Site 125 | Evansville | Indiana |
| United States | Teva Investigational Site 116 | Fullerton | California |
| United States | Teva Investigational Site 145 | Gilbert | Arizona |
| United States | Teva Investigational Site 150 | Golden Valley | Minnesota |
| United States | Teva Investigational Site 120 | Goose Creek | South Carolina |
| United States | Teva Investigational Site 131 | Greensboro | North Carolina |
| United States | Teva Investigational Site 137 | Hialeah | Florida |
| United States | Teva Investigational Site 159 | Hollywood | Florida |
| United States | Teva Investigational Site 101 | Jacksonville | Florida |
| United States | Teva Investigational Site 166 | Jacksonville | Florida |
| United States | Teva Investigational Site 114 | Kalamazoo | Michigan |
| United States | Teva Investigational Site 152 | Kansas City | Missouri |
| United States | Teva Investigational Site 133 | Lenexa | Kansas |
| United States | Teva Investigational Site 158 | Little Rock | Arkansas |
| United States | Teva Investigational Site 119 | Long Beach | California |
| United States | Teva Investigational Site 129 | Maitland | Florida |
| United States | Teva Investigational Site 156 | Mansfield | Texas |
| United States | Teva Investigational Site 126 | Memphis | Tennessee |
| United States | Teva Investigational Site 154 | Nashville | Tennessee |
| United States | Teva Investigational Site 124 | New Bedford | Massachusetts |
| United States | Teva Investigational Site 146 | Oceanside | California |
| United States | Teva Investigational Site 127 | Oklahoma City | Oklahoma |
| United States | Teva Investigational Site 167 | Orlando | Florida |
| United States | Teva Investigational Site 139 | Ormond Beach | Florida |
| United States | Teva Investigational Site 111 | Philadelphia | Pennsylvania |
| United States | Teva Investigational Site 130 | Phoenix | Arizona |
| United States | Teva Investigational Site 140 | Port Orange | Florida |
| United States | Teva Investigational Site 118 | Raleigh | North Carolina |
| United States | Teva Investigational Site 165 | Raleigh | North Carolina |
| United States | Teva Investigational Site 148 | Reno | Nevada |
| United States | Teva Investigational Site 144 | Roanoke | Virginia |
| United States | Teva Investigational Site 104 | Saint Louis | Missouri |
| United States | Teva Investigational Site 157 | Salt Lake City | Utah |
| United States | Teva Investigational Site 113 | San Francisco | California |
| United States | Teva Investigational Site 117 | Scottsdale | Arizona |
| United States | Teva Investigational Site 160 | South Miami | Florida |
| United States | Teva Investigational Site 107 | Springfield | Missouri |
| United States | Teva Investigational Site 151 | Springfield | Massachusetts |
| United States | Teva Investigational Site 162 | Stamford | Connecticut |
| United States | Teva Investigational Site 108 | Stanford | California |
| United States | Teva Investigational Site 112 | Walnut Creek | California |
| United States | Teva Investigational Site 109 | Watertown | Massachusetts |
| United States | Teva Investigational Site 168 | Winston-Salem | North Carolina |
| United States | Teva Investigational Site 115 | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | NCGS, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With 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 | |
| Primary | Number of Participants With at Least One Adverse Event | 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 | |
| Primary | Number of Participants Reporting Mild, Moderate, and Severe Adverse Events (AEs) | 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 | Change From Baseline in Number of Days With Headache of Any Severity | 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 |