A Study Of Galcanezumab In Participants With Episodic Cluster Headache (NCT02397473) | Clinical Trial Compass
CompletedPhase 3
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
United States109 participantsStarted 2015-05-22
Plain-language 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 cluster headaches.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
What they're measuring
1
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks