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

This study has been completed.

First Received on April 11, 2002. Last Updated on June 8, 2011 History of Changes

Sponsor:	Winston Laboratories
Information provided by:	Winston Laboratories
ClinicalTrials.gov Identifier:	NCT00033839

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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: Zucapsaicin

U.S. FDA Resources

Further study details as provided by Winston Laboratories:

Estimated Enrollment:	60
Study Start Date:	January 2002
Study Completion Date:	July 2003
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

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 16 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: NCT00033839

Show 26 Study Locations

Sponsors and Collaborators

Winston Laboratories

Investigators

Study Director:

Scott B. Phillips, M.D.

Winston Laboratories

More Information

No publications provided

Responsible Party:	Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00033839 History of Changes
Other Study ID Numbers:	WL-1001-02-02
Study First Received:	April 11, 2002
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