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A Study Of Galcanezumab In Participants With Episodic Cluster Headache

Principal Investigator

Teshamae Monteith

Clinical Trial ID

Institutional Protocol # 20150349
National Clinical Trials Identifier NCT02397473

Clinical Trial Summary


Phase

Phase 3


Funding Agency/Sponsor

Industry


Disease


Enrollment 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.


Contact Information

Study Contact Neurology Research
Phone Number 1-877-977-7724
Get detailed information on ClinicalTrials.Gov