Assessment of LBR-101 In Chronic Migraine

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Migraine

Treatments: Drug: LBR-101 Low Dose; Drug: Placebo; Drug: LBR-101 High Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02021773

LBR-101-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 3 patient groups, including a placebo group

LBR-101 High Dose

Experimental group

Description:

Subcutaneous High Dose LBR-101 Administered Monthly x 3

Treatment:

Drug: LBR-101 High Dose

LBR-101 Low Dose

Experimental group

Description:

Subcutaneous Low Dose LBR-101 Administered Monthly x 3

Treatment:

Drug: LBR-101 Low Dose

Placebo

Placebo Comparator group

Description:

Subcutaneous Placebo Administered Monthly x 3

Treatment:

Drug: Placebo