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A Study Of Galcanezumab In Participants With Episodic Cluster Headache
Recruiting
Trial ID: NCT02397473
Purpose
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.
Official Title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache
Eligibility
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.
Intervention(s):
drug: Placebo
drug: Galcanezumab
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
650-723-5184