Phase 2
N=264
Assessment of LBR-101 In Chronic Migraine
Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02021773 ↗Enrolled (actual)
264
Serious AEs
1.5%
Results posted
Nov 2021
Primary outcome: 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 — -37.10; -59.84; -67.51 Number of monthly headache hours — p=0.0386
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LBR-101 High Dose (Drug); LBR-101 Low Dose (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-37.10; -59.84; -67.51 | 0.0386 sig |
| PRIMARY Number of Participants With at Least One Adverse Event |
36; 47; 41 | — |
| 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 |
-4.20; -6.04; -6.16 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02021773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.