Intranasal Civamide for Episodic Cluster Headache
This study has been completed.
Sponsor:
Winston Laboratories
Information provided by:
Winston Laboratories
ClinicalTrials.gov Identifier:
NCT00069082
First received: September 15, 2003
Last updated: June 8, 2011
Last verified: June 2011
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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
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 Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013