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

June 8, 2011 updated by: Winston Laboratories

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Valley Neurological Headache & Research Center
      • Tucson, Arizona, United States, 85712
        • Neurological Associates of Tucson
    • California
      • Mountain View, California, United States, 94040
        • Northern California Headache Clinic
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • Santa Monica, California, United States, 90404
        • California Medical Clinic for Headache
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • New England Center for Headache, PC
    • Florida
      • Plantation, Florida, United States, 33324
        • Neurology Clinical Research, Inc.
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Neurology and Headache Specialists of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Diamond Headache Clinic
    • Massachusetts
      • Wellesley Hills, Massachusetts, United States, 02481
        • Boston Clinical Research Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Headache Pain & Neurological Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Department of Neurology
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Department of Neurology Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Mercy Health Research
      • Springfield, Missouri, United States, 65804
        • Headache Care Center/Clinvest
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10021
        • New York Headache Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • The Headache Wellness Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati Headache Clinic
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Neurological Associates of Tulsa, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Headache Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Neuroscience Center
    • Texas
      • Houston, Texas, United States, 77004
        • Houston Headache Clinic
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • The Neurology and Headache Treatment Center (Innovative Clinical Research)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winston Laboratories

Investigators

  • Study Director: Scott B. Phillips, M.D., Winston Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

July 1, 2003

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

April 11, 2002

First Submitted That Met QC Criteria

April 11, 2002

First Posted (Estimate)

April 12, 2002

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WL-1001-02-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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