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Sponsored by: |
Winston Laboratories |
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Information provided by: | Winston Laboratories |
ClinicalTrials.gov Identifier: | NCT00069082 |
This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).
Condition | Intervention | Phase |
---|---|---|
Episodic Cluster Headache |
Drug: Civamide (Zucapsaicin) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, California | |
San Francisco Clinical Research Center | |
San Francisco, California, United States | |
California Medical Clinic for Headache | |
Santa Monica, California, United States | |
United States, Colorado | |
Colorado Neurology and Headache Clinic | |
Denver, Colorado, United States, 80218 | |
United States, Illinois | |
Diamond Headache Clinic | |
Chicago, Illinois, United States | |
United States, New York | |
New York Headache Center | |
New York, New York, United States | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States |
Study Director: | Scott B Phillips, MD | Winston Laboratories |
Study ID Numbers: | WL-1001-02-05 |
Study First Received: | September 15, 2003 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00069082 |
Health Authority: | United States: Food and Drug Administration |
Headache Cluster EC Episodic Cluster |
Cluster Headache Signs and Symptoms Headache Neurologic Manifestations Central Nervous System Diseases |
Pain Headache Disorders, Primary Brain Diseases Headache Disorders |
Trigeminal Autonomic Cephalalgias Nervous System Diseases |