A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine

Phase 2

Completed

Conditions: Episodic Migraine Headache

Interventions: Drug: LBR-101 High Dose
Drug: Placebo
Drug: 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

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.

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 145
🇺🇸
Gilbert, Arizona, United States
Teva Investigational Site 130
🇺🇸
Phoenix, Arizona, United States
Teva Investigational Site 117
🇺🇸
Scottsdale, Arizona, United States
Teva Investigational Site 158
🇺🇸
Little Rock, Arkansas, United States
Teva Investigational Site 161
🇺🇸
Anaheim, California, United States
Teva Investigational Site 116
🇺🇸
Fullerton, California, United States
Teva Investigational Site 119
🇺🇸
Long Beach, California, United States
Teva Investigational Site 146
🇺🇸
Oceanside, California, United States
Teva Investigational Site 113
🇺🇸
San Francisco, California, United States
Teva Investigational Site 108
🇺🇸
Stanford, California, United States
Scroll for more (53 remaining)
Teva Investigational Site 145
🇺🇸Gilbert, Arizona, United States