A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Chronic Migraine - the REGAIN Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 54

Inclusion Criteria

Patients are 18 to 65 years of age (inclusive) at the time of screening.;Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta.;Migraine onset prior to age 50.

Exclusion Criteria

Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.;Current use or prior exposure to LY2951742 or another CGRP antibody;Are currently receiving medication or other treatments for the prevention of migraine headaches.;Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to LY2951742.;History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The overall mean change from baseline in the number of monthly migraine<br /><br>headache days during the 3-month double-blind treatment phase</p><br>

Secondary Outcome Measures

Name	Time	Method

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Recruitment & Eligibility

Study & Design

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