Intranasal Civamide for Episodic Cluster Headache - Full Text View

Intranasal Civamide for Episodic Cluster Headache

This study has been completed.

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

MedlinePlus related topics:

Headache

Drug Information available for:

Salicylsalicylic acid Sodium salicylate Zucapsaicin

U.S. FDA Resources

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

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

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

Keywords provided by Winston Laboratories:

Headache

Cluster

Episodic Cluster

Study placed in the following topic categories:

Cluster Headache

Signs and Symptoms

Salicylsalicylic acid

Headache

Sodium Salicylate

Neurologic Manifestations

Central Nervous System Diseases

Pain

Headache Disorders, Primary

Brain Diseases

Headache Disorders

Additional relevant MeSH terms:

Trigeminal Autonomic Cephalalgias

Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008