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

Sponsor

Winston Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT00033839

Collaborator

(none)

Enrollment

Locations

17.9

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Episodic Cluster Headache	Drug: Civamide (Zucapsaicin)	Phase 3

Study Design

Study Type:

Interventional

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 :

Jan 1, 2002

Actual Primary Completion Date :

Jul 1, 2003

Actual Study Completion Date :

Jul 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Valley Neurological Headache & Research Center	Phoenix	Arizona	United States	85020
2	Neurological Associates of Tucson	Tucson	Arizona	United States	85712
3	Northern California Headache Clinic	Mountain View	California	United States	94040
4	San Francisco Clinical Research Center	San Francisco	California	United States	94109
5	California Medical Clinic for Headache	Santa Monica	California	United States	90404
6	New England Center for Headache, PC	Stamford	Connecticut	United States	06902
7	Neurology Clinical Research, Inc.	Plantation	Florida	United States	33324
8	Neurology and Headache Specialists of Atlanta	Decatur	Georgia	United States	30033
9	Diamond Headache Clinic	Chicago	Illinois	United States	60614
10	Boston Clinical Research Center	Wellesley Hills	Massachusetts	United States	02481
11	Michigan Headache Pain & Neurological Institute	Ann Arbor	Michigan	United States	48104
12	Henry Ford Hospital Department of Neurology	Detroit	Michigan	United States	48202
13	Department of Neurology Mayo Clinic	Rochester	Minnesota	United States	55905
14	Mercy Health Research	Chesterfield	Missouri	United States	63017
15	Headache Care Center/Clinvest	Springfield	Missouri	United States	65804
16	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
17	New York Headache Center	New York	New York	United States	10021
18	The Headache Wellness Center	Greensboro	North Carolina	United States	27401
19	Cincinnati Headache Clinic	Cincinnati	Ohio	United States	45219
20	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
21	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
22	Neurological Associates of Tulsa, Inc.	Tulsa	Oklahoma	United States	74136
23	Jefferson Headache Center	Philadelphia	Pennsylvania	United States	19107
24	Nashville Neuroscience Center	Nashville	Tennessee	United States	37203
25	Houston Headache Clinic	Houston	Texas	United States	77004
26	The Neurology and Headache Treatment Center (Innovative Clinical Research)	Alexandria	Virginia	United States	22304