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

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Winston Laboratories
• Treatments: Capsaicin

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