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A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

NCT00033839•Winston Laboratories

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (26)

Valley Neurological Headache & Research Center

Phoenix, Arizona, United States

Neurological Associates of Tucson

Tucson, Arizona, United States

Northern California Headache Clinic

Mountain View, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

California Medical Clinic for Headache

Santa Monica, California, United States

New England Center for Headache, PC

Stamford, Connecticut, United States

Neurology Clinical Research, Inc.

Plantation, Florida, United States

Neurology and Headache Specialists of Atlanta

Decatur, Georgia, United States

Diamond Headache Clinic

Chicago, Illinois, United States

Boston Clinical Research Center

Wellesley Hills, Massachusetts, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

July 1, 2003

Completion Date

July 1, 2003

Last Updated

June 10, 2011

Enrollment

Estimated participants

Conditions

Episodic Cluster Headache

Interventions

Civamide (Zucapsaicin)

DRUG

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

NCT02945046

Episodic Cluster Headache

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TERMINATEDPHASE2

R-Verapamil for the Prophylaxis of Episodic Cluster Headache

NCT02209155

Episodic Cluster Headache

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UNKNOWNPHASE4

Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache

NCT00399243

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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