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