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

Episodic Cluster Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033839
• Other study ID #: WL-1001-02-02
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2002
• Last updated: June 8, 2011
• Start date: January 2002
• Est. completion date: July 2003

Study information

• Verified date: June 2011
• Source: Winston Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cluster Headache
• Episodic Cluster Headache
• Headache

Intervention

Drug:
• Civamide (Zucapsaicin)

Locations

Country	Name	City	State
United States	The Neurology and Headache Treatment Center (Innovative Clinical Research)	Alexandria	Virginia
United States	Michigan Headache Pain & Neurological Institute	Ann Arbor	Michigan
United States	Mercy Health Research	Chesterfield	Missouri
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Cincinnati Headache Clinic	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Neurology and Headache Specialists of Atlanta	Decatur	Georgia
United States	Henry Ford Hospital Department of Neurology	Detroit	Michigan
United States	The Headache Wellness Center	Greensboro	North Carolina
United States	Houston Headache Clinic	Houston	Texas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Northern California Headache Clinic	Mountain View	California
United States	Nashville Neuroscience Center	Nashville	Tennessee
United States	New York Headache Center	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Valley Neurological Headache & Research Center	Phoenix	Arizona
United States	Neurology Clinical Research, Inc.	Plantation	Florida
United States	Department of Neurology Mayo Clinic	Rochester	Minnesota
United States	San Francisco Clinical Research Center	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Headache Care Center/Clinvest	Springfield	Missouri
United States	New England Center for Headache, PC	Stamford	Connecticut
United States	Neurological Associates of Tucson	Tucson	Arizona
United States	Neurological Associates of Tulsa, Inc.	Tulsa	Oklahoma
United States	Boston Clinical Research Center	Wellesley Hills	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Winston Laboratories

Country where clinical trial is conducted

United States,