Title
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
Phase
Phase 3Lead Sponsor
Winston LaboratoriesStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Episodic Cluster HeadacheIntervention/Treatment
zucapsaicin ...Study Participants
60This 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).
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