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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Episodic Migraine Headache

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02025556

LBR-101-022

Details and patient eligibility

About

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.

Enrollment: 297 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.

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

297 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