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

This study has been completed.
Information provided by:
Winston Laboratories Identifier:
First received: April 11, 2002
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)
Phase 3

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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 16 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: NCT00033839

  Show 26 Study Locations
Sponsors and Collaborators
Winston Laboratories
Study Director: Scott B. Phillips, M.D. Winston Laboratories
  More Information

Responsible Party: Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc. 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:
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
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on October 27, 2016