A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

Last updated: June 8, 2011
Sponsor: Winston Laboratories
Overall Status: Completed

Phase

3

Condition

Acute Pain

Trigeminal Neuralgia

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00033839
WL-1001-02-02
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

  • 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

Study Design

Total Participants: 60
Study Start date:
January 01, 2002
Estimated Completion Date:
July 31, 2003

Connect with a study center

  • Valley Neurological Headache & Research Center

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Neurological Associates of Tucson

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Northern California Headache Clinic

    Mountain View, California 94040
    United States

    Site Not Available

  • San Francisco Clinical Research Center

    San Francisco, California 94109
    United States

    Site Not Available

  • California Medical Clinic for Headache

    Santa Monica, California 90404
    United States

    Site Not Available

  • New England Center for Headache, PC

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • Neurology Clinical Research, Inc.

    Plantation, Florida 33324
    United States

    Site Not Available

  • Neurology and Headache Specialists of Atlanta

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Diamond Headache Clinic

    Chicago, Illinois 60614
    United States

    Site Not Available

  • Boston Clinical Research Center

    Wellesley Hills, Massachusetts 02481
    United States

    Site Not Available

  • Michigan Headache Pain & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Henry Ford Hospital Department of Neurology

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Department of Neurology Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mercy Health Research

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Headache Care Center/Clinvest

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • New York Headache Center

    New York, New York 10021
    United States

    Site Not Available

  • The Headache Wellness Center

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Cincinnati Headache Clinic

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Neurological Associates of Tulsa, Inc.

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Jefferson Headache Center

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Nashville Neuroscience Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Houston Headache Clinic

    Houston, Texas 77004
    United States

    Site Not Available

  • The Neurology and Headache Treatment Center (Innovative Clinical Research)

    Alexandria, Virginia 22304
    United States

    Site Not Available

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