A Study Of Galcanezumab In Participants With Episodic Cluster Headache

Completed · Phase 3 · Has a placebo group

Conditions studied: Episodic Cluster Headache

In brief

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

Key facts

Study ID

NCT02397473

Run by

Eli Lilly and Company

People needed

109

Starts

2015-05-22

Expected to finish

2018-06-04

Last updated by the study team

2019-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1 month.
• 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

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Stanford University Hospital — Palo Alto, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• St. Anthony's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Atlanta Center of Medical Research — Atlanta, Georgia, United States
• Michigan Head, Pain, and Neurological Institute — Ann Arbor, Michigan, United States
• ClinVest — Springfield, Missouri, United States
• Dent Neurological Institute — Amherst, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Clinical Trials of South Carolina — Charleston, South Carolina, 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 1-888-545-5972 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, 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Jyväskylä, 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.