Phase 2
Completed N=297
A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
Episodic Migraine Headache
Source: ClinicalTrials.gov NCT02025556 ↗
Enrolled (actual)
297
Serious AEs
1.4%
Results posted
Jan 2022
Primary outcomePrimary: Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With Week 12 — -3.46; -6.27; -6.09 Days — p=< .0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With Week 12 |
-3.46; -6.27; -6.09 | < .0001 sig |
| PRIMARY Number of Participants With at Least One Adverse Event |
58; 44; 57 | — |
| PRIMARY Number of Participants Reporting Mild, Moderate, and Severe Adverse Events (AEs) |
29; 20; 31; 27; 20; 26 | — |
| SECONDARY Change From Baseline in Number of Days With Headache of Any Severity |
-3.52; -6.14; -6.10 | — |
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02025556). 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. Informational only — not medical advice.