Back to resultsA Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache
Primary Purpose
Episodic Cluster Headache
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Civamide (Zucapsaicin)
Sponsored by
About this trial
This is an interventional treatment trial for Episodic Cluster Headache focused on measuring Headache, Cluster, EC, Episodic Cluster
Eligibility 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
Sites / Locations
- Valley Neurological Headache & Research Center
- Neurological Associates of Tucson
- Northern California Headache Clinic
- San Francisco Clinical Research Center
- California Medical Clinic for Headache
- New England Center for Headache, PC
- Neurology Clinical Research, Inc.
- Neurology and Headache Specialists of Atlanta
- Diamond Headache Clinic
- Boston Clinical Research Center
- Michigan Headache Pain & Neurological Institute
- Henry Ford Hospital Department of Neurology
- Department of Neurology Mayo Clinic
- Mercy Health Research
- Headache Care Center/Clinvest
- Dartmouth Hitchcock Medical Center
- New York Headache Center
- The Headache Wellness Center
- Cincinnati Headache Clinic
- Cleveland Clinic Foundation
- University of Oklahoma
- Neurological Associates of Tulsa, Inc.
- Jefferson Headache Center
- Nashville Neuroscience Center
- Houston Headache Clinic
- The Neurology and Headache Treatment Center (Innovative Clinical Research)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00033839
Brief Title
A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Winston Laboratories
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Cluster Headache
Keywords
Headache, Cluster, EC, Episodic Cluster
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Civamide (Zucapsaicin)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott B. Phillips, M.D.
Organizational Affiliation
Winston Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Valley Neurological Headache & Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Neurological Associates of Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Northern California Headache Clinic
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
New England Center for Headache, PC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Neurology Clinical Research, Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Neurology and Headache Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Boston Clinical Research Center
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Michigan Headache Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Henry Ford Hospital Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Department of Neurology Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mercy Health Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Headache Care Center/Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New York Headache Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Cincinnati Headache Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Neurological Associates of Tulsa, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Nashville Neuroscience Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Houston Headache Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
The Neurology and Headache Treatment Center (Innovative Clinical Research)
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache
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