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Intranasal Civamide for Episodic Cluster Headache

This study has been completed.
Sponsor:
Information provided by:
Winston Laboratories
ClinicalTrials.gov Identifier:
NCT00069082
First received: September 15, 2003
Last updated: June 8, 2011
Last verified: June 2011
  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)
Drug: Sodium Chloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 ClinicalTrials.gov identifier: NCT00069082

Locations
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
Investigators
Study Director: Scott B Phillips, MD Winston Laboratories
  More Information

No publications provided

Responsible Party: Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00069082     History of Changes
Other Study ID Numbers: WL-1001-02-05
Study First Received: September 15, 2003
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Winston Laboratories:
Headache
Cluster
EC
Episodic Cluster

Additional relevant MeSH terms:
Cluster Headache
Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014