A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
Condition: Episodic Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: LBR-101 High Dose; LBR-101 Low Dose; Placebo
Intervention description: Subcutaneously Administered High Dose LBR-101 Monthly x 3; Subcutaneously Administered Low Dose LBR-101 Monthly x 3; Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 297.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: High Frequency Episodic Migraine Headache; Episodic Migraine Headache; Migraine Headache

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.
    

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.