Clinical trial NCT00033839: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Cluster Headache
Keywords: Headache
Cluster
EC
Episodic Cluster
Lead sponsor: Winston Laboratories
Sponsor class: INDUSTRY
First posted: 2002-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Neurological Headache & Research Center
state: Arizona
city: Tucson
country: United States
facility: Neurological Associates of Tucson
state: Arizona
city: Mountain View
country: United States
facility: Northern California Headache Clinic
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Stamford
country: United States
facility: New England Center for Headache, PC
state: Connecticut
city: Plantation
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: Decatur
country: United States
facility: Neurology and Headache Specialists of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Wellesley Hills
country: United States
facility: Boston Clinical Research Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache Pain & Neurological Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Department of Neurology
state: Michigan
city: Rochester
country: United States
facility: Department of Neurology Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Headache Care Center/Clinvest
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: New York Headache Center
state: New York
city: Greensboro
country: United States
facility: The Headache Wellness Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Headache Clinic
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Neurological Associates of Tulsa, Inc.
state: Oklahoma
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Neuroscience Center
state: Tennessee
city: Houston
country: United States
facility: Houston Headache Clinic
state: Texas
city: Alexandria
country: United States
facility: The Neurology and Headache Treatment Center (Innovative Clinical Research)
state: Virginia
Study officials:
affiliation: Winston Laboratories
name: Scott B. Phillips, M.D.
role: STUDY_DIRECTOR
References: