Assessment of LBR-101 In Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021773
• Other study ID #: LBR-101-021
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2014
• Est. completion date: March 31, 2015

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: March 31, 2015
• Est. primary completion date: February 28, 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.
• 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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• LBR-101 High Dose
Subcutaneously Administered LBR-101 Monthly x 3
• LBR-101 Low Dose
Subcutaneously Administered LBR-101 Monthly x 3
• Placebo
Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Locations

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 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 119	Long Beach	California
United States	Teva Investigational Site 129	Maitland	Florida
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 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 113	San Francisco	California
United States	Teva Investigational Site 117	Scottsdale	Arizona
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

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
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
Secondary	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	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