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

NCT ID: NCT00033839

Last Updated: 2011-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Episodic Cluster Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Civamide (Zucapsaicin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Winston Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Winston Laboratories, Inc.

Principal Investigators

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Scott B. Phillips, M.D.

Role: STUDY_DIRECTOR

Winston Laboratories

Locations

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Valley Neurological Headache & Research Center

Phoenix, Arizona, United States

Site Status

Neurological Associates of Tucson

Tucson, Arizona, United States

Site Status

Northern California Headache Clinic

Mountain View, California, United States

Site Status

San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

California Medical Clinic for Headache

Santa Monica, California, United States

Site Status

New England Center for Headache, PC

Stamford, Connecticut, United States

Site Status

Neurology Clinical Research, Inc.

Plantation, Florida, United States

Site Status

Neurology and Headache Specialists of Atlanta

Decatur, Georgia, United States

Site Status

Diamond Headache Clinic

Chicago, Illinois, United States

Site Status

Boston Clinical Research Center

Wellesley Hills, Massachusetts, United States

Site Status

Michigan Headache Pain & Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Henry Ford Hospital Department of Neurology

Detroit, Michigan, United States

Site Status

Department of Neurology Mayo Clinic

Rochester, Minnesota, United States

Site Status

Mercy Health Research

Chesterfield, Missouri, United States

Site Status

Headache Care Center/Clinvest

Springfield, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

New York Headache Center

New York, New York, United States

Site Status

The Headache Wellness Center

Greensboro, North Carolina, United States

Site Status

Cincinnati Headache Clinic

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Neurological Associates of Tulsa, Inc.

Tulsa, Oklahoma, United States

Site Status

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Site Status

Nashville Neuroscience Center

Nashville, Tennessee, United States

Site Status

Houston Headache Clinic

Houston, Texas, United States

Site Status

The Neurology and Headache Treatment Center (Innovative Clinical Research)

Alexandria, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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WL-1001-02-02

Identifier Type: -

Identifier Source: org_study_id

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