Intranasal Civamide for Episodic Cluster Headache

Phase 3

Completed

• Conditions: Episodic Cluster Headache
• Interventions: Drug: Civamide (Zucapsaicin); Drug: Sodium Chloride

• Registration Number: NCT00069082
• Lead Sponsor: Winston Laboratories

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2003-09-15
• Study First Submitted QC: 2003-09-15
• Study First Posted: 2003-09-16
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Civamide	Civamide (Zucapsaicin)	Nasal Solution 0.01%
Placebo	Sodium Chloride	Placebo nasal solution with sodium chloride 10%

Trial Locations

Locations (6)

California Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States

Diamond Headache Clinic; 🇺🇸 Chicago, Illinois, United States

Colorado Neurology and Headache Clinic; 🇺🇸 Denver, Colorado, United States

San Francisco Clinical Research Center; 🇺🇸 San Francisco, California, United States

New York Headache Center; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States