Intranasal Civamide for Episodic Cluster Headache - Full Text View

Sponsor:	Winston Laboratories
Information provided by:	Winston Laboratories
ClinicalTrials.gov Identifier:	NCT00069082

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) Drug: Sodium Chloride	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

MedlinePlus related topics: Headache

Drug Information available for: Chlorides Zucapsaicin Sodium chloride

U.S. FDA Resources

Further study details as provided by Winston Laboratories:

Enrollment:	2
Study Start Date:	August 2003
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Civamide Nasal Solution 0.01%	Drug: Civamide (Zucapsaicin) Nasal Solution 0.01%
Placebo Comparator: Placebo Placebo nasal solution with sodium chloride 10%	Drug: Sodium Chloride Nasal Solution 10%

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 24 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: NCT00069082

Locations

United States, California
San Francisco Clinical Research Center
San Francisco, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
United States, Colorado
Colorado Neurology and Headache Clinic
Denver, Colorado, United States, 80218
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States
United States, New York
New York Headache Center
New York, New York, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States

Sponsors and Collaborators

Winston Laboratories

Investigators

Study Director:

Scott B Phillips, MD

Winston Laboratories

More Information

No publications provided

Responsible Party:	Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00069082 History of Changes
Other Study ID Numbers:	WL-1001-02-05
Study First Received:	September 15, 2003
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Winston Laboratories:

Headache
Cluster
EC
Episodic Cluster

Additional relevant MeSH terms:

Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012