Intranasal Civamide for Episodic Cluster Headache

Episodic Cluster Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069082
• Other study ID #: WL-1001-02-05
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2003
• Last updated: June 8, 2011
• Start date: August 2003
• Est. completion date: January 2004

Study information

• Verified date: June 2011
• Source: Winston Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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 24 weeks

• At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cluster Headache
• Episodic Cluster Headache
• Headache

Intervention

Drug:
• Civamide (Zucapsaicin)
Nasal Solution 0.01%
• Sodium Chloride
Nasal Solution 10%

Locations

Country	Name	City	State
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Colorado Neurology and Headache Clinic	Denver	Colorado
United States	New York Headache Center	New York	New York
United States	San Francisco Clinical Research Center	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Winston Laboratories

Country where clinical trial is conducted

United States,