Intranasal Civamide for Episodic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00069082
Recruitment Status : Completed
First Posted : September 16, 2003
Last Update Posted : June 10, 2011
Information provided by:
Winston Laboratories

Brief 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).

Condition or disease Intervention/treatment Phase
Episodic Cluster Headache Drug: Civamide (Zucapsaicin) Drug: Sodium Chloride Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2003
Primary Completion Date : January 2004
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
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%

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00069082

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
Study Director: Scott B Phillips, MD Winston Laboratories

Responsible Party: Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc. Identifier: NCT00069082     History of Changes
Other Study ID Numbers: WL-1001-02-05
First Posted: September 16, 2003    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Winston Laboratories:
Episodic Cluster

Additional relevant MeSH terms:
Cluster Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Pharmaceutical Solutions
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs