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

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ClinicalTrials.gov Identifier: NCT00033839
Recruitment Status : Completed
First Posted : April 12, 2002
Last Update Posted : June 10, 2011
Sponsor:
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) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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
Study Start Date : January 2002
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources





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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

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

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 Posted: April 12, 2002    Key Record Dates
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