Intranasal Civamide for Episodic Cluster Headache

This study has been completed.

First Received: September 15, 2003 Last Updated: February 25, 2008 History of Changes

Sponsored by:	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)	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:

MedlinePlus related topics: Headache

Drug Information available for: Zucapsaicin

U.S. FDA Resources

Further study details as provided by Winston Laboratories:

Estimated Enrollment:	30
Study Start Date:	August 2003

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

Study ID Numbers:	WL-1001-02-05
Study First Received:	September 15, 2003
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00069082 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Winston Laboratories:

Headache
Cluster
EC
Episodic Cluster

Study placed in the following topic categories:

Cluster Headache
Signs and Symptoms
Headache
Cluster Headaches
Neurologic Manifestations

Central Nervous System Diseases
Pain
Headache Disorders, Primary
Brain Diseases
Headache Disorders

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 July 02, 2009