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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00033839
First Posted: April 12, 2002
Last Update Posted: June 10, 2011
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.
Information provided by:
Winston Laboratories
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00033839


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

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
First Submitted: April 11, 2002
First Posted: April 12, 2002
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Winston Laboratories:
Headache
Cluster
EC
Episodic Cluster

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