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A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache
This study has been completed.
First Received: April 11, 2002   Last Updated: June 23, 2005   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Winston Laboratories:

Estimated Enrollment: 60
Study Start Date: January 2002
Estimated Study Completion Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • At least 2 year history of episodic cluster headache (meeting IHS criteria)
  • At least 2 previous episodes
  • Expected duration of cluster period is at least 6 weeks but not longer than 16 weeks
  • At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033839

  Hide Study Locations
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
Sponsors and Collaborators
Winston Laboratories
Investigators
Study Director: Scott B. Phillips, M.D. Winston Laboratories
  More Information

No publications provided

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

Keywords provided by Winston Laboratories:
Headache
Cluster
EC
Episodic Cluster

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009