Evaluation of Galcanezumab in the Prevention of Chronic Migraine
CompletedPhase 3NCT02614261
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.
Study details
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
- Conditions
- Interventions
- Drug: Galcanezumab
- Drug: Placebo
- Sponsor
- Eli Lilly and Company
- Start date
- 2015-11-30
- Primary completion
- 2017-03-16
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Argentina, Canada, Czechia, Germany, Israel, Italy, Mexico, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom, United States
- Total sites listed
- 117
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Main Study: * Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. Israel addendum: * Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered. * Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine. 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.
Canadian sites (4)
| Facility | City | Province |
|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Brampton | |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Kelowna | |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Montreal | |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Ottawa |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02614261