A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

• Status: Completed
• Trial end date: 2019-09-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have a diagnosis of migraine or chronic migraine.

• History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.

• History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.

• Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.

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 galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.

• 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).

• Pregnant or nursing.