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| Sponsor: | Winston Laboratories |
|---|---|
| Information provided by: | Winston Laboratories |
| ClinicalTrials.gov Identifier: | NCT00033839 |
Purpose
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Neurological Associates of Tucson | |
| Tucson, Arizona, United States, 85712 | |
| Valley Neurological Headache & Research Center | |
| Phoenix, Arizona, United States, 85020 | |
| United States, California | |
| San Francisco Clinical Research Center | |
| San Francisco, California, United States, 94109 | |
| California Medical Clinic for Headache | |
| Santa Monica, California, United States, 90404 | |
| Northern California Headache Clinic | |
| Mountain View, California, United States, 94040 | |
| United States, Connecticut | |
| New England Center for Headache, PC | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Florida | |
| Neurology Clinical Research, Inc. | |
| Plantation, Florida, United States, 33324 | |
| United States, Georgia | |
| Neurology and Headache Specialists of Atlanta | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Diamond Headache Clinic | |
| Chicago, Illinois, United States, 60614 | |
| United States, Massachusetts | |
| Boston Clinical Research Center | |
| Wellesley Hills, Massachusetts, United States, 02481 | |
| United States, Michigan | |
| Michigan Headache Pain & Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| Henry Ford Hospital Department of Neurology | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Department of Neurology Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Headache Care Center/Clinvest | |
| Springfield, Missouri, United States, 65804 | |
| Mercy Health Research | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| New York Headache Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| The Headache Wellness Center | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Cincinnati Headache Clinic | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Neurological Associates of Tulsa, Inc. | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Jefferson Headache Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Nashville Neuroscience Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Houston Headache Clinic | |
| Houston, Texas, United States, 77004 | |
| United States, Virginia | |
| The Neurology and Headache Treatment Center (Innovative Clinical Research) | |
| Alexandria, Virginia, United States, 22304 | |
| Study Director: | Scott B. Phillips, M.D. | Winston Laboratories |
More Information
| Study ID Numbers: | WL-1001-02-02 |
| Study First Received: | April 11, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00033839 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Headache Cluster EC Episodic Cluster |
|
Cluster Headache Signs and Symptoms Trigeminal Autonomic Cephalalgias Nervous System Diseases Headache Neurologic Manifestations |
Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Headache Disorders |