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Intranasal Civamide for Episodic Cluster Headache

This study has been completed.
Information provided by:
Winston Laboratories Identifier:
First received: September 15, 2003
Last updated: June 8, 2011
Last verified: June 2011
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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%


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: September 15, 2003
Last Updated: June 8, 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 processed this record on September 21, 2017