A Study of Galcanezumab in Participants With Chronic Cluster Headache
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Cluster Headache
In brief
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.
Key facts
- Study ID
- NCT02438826
- Run by
- Eli Lilly and Company
- People needed
- 240
- Starts
- 2015-06-18
- Expected to finish
- 2019-08-14
- Last updated by the study team
- 2020-08-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
- Participants are able to distinguish cluster headache attacks from other headaches.
You may not qualify if…
- Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
- Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
- Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
- A history of migraine variants that could implicate or could be confused with ischemia.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
- A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
- Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
- Women who are pregnant or nursing.
Where it is running
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- California Medical Clinic for Headache — Santa Monica, California, United States
- Stanford University Hospital — Stanford, California, United States
- Colorado Neurological Institute — Englewood, Colorado, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- New England Institute for Clinical Research — Stamford, Connecticut, United States
- Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Michigan Head, Pain and Neurological Institute — Ann Arbor, Michigan, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Southwestern Medical Center - Dallas — Dallas, Texas, United States
- Northwest Clinical Research Center — Bellevue, Washington, United States
- West Virginia University Hospital — Morgantown, West Virginia, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Ghent, Belgium
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Liège, Belgium
- 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, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Montreal, Canada
- 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. — Toronto, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Glostrup Municipality, Denmark
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Glostrup Municipality, Denmark
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Helsinki, Finland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Turku, Finland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Lille, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Marseille, France
Full record on ClinicalTrials.gov
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