Overview

Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

Status:
Completed
Trial end date:
2018-10-05
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic migraine.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Criteria
Inclusion Criteria:

- Have a diagnosis of migraine as defined by International Headache Society (IHS)
International Classification of Headache Disorders (ICHD)-3 beta version (1.1 or 1.2)
(ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MHD.

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.

- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
proteins, or to galcanezumab.

- 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.