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).

Condition	Treatment or Intervention	Phase
Episodic Cluster Headache	Drug: Civamide (Zucapsaicin)	Phase III

Further Study Details: 

Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      San Francisco Clinical Research Center, San Francisco,  California,  United States
      California Medical Clinic for Headache, Santa Monica,  California,  United States
Colorado
      Colorado Neurology and Headache Clinic, Denver,  Colorado,  80218,  United States
Illinois
      Diamond Headache Clinic, Chicago,  Illinois,  United States
New York
      New York Headache Center, New York,  New York,  United States
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  United States

Study chairs or principal investigators

Scott B Phillips, MD,  Study Director,  Winston Laboratories   

Study ID Numbers:  WL-1001-02-05
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  September 15, 2003
ClinicalTrials.gov Identifier:  NCT00069082
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08