This is a double-blind, randomized, vehicle-controlled, parallel-group, multi-center, phase III efficacy and safety study of civamide nasal solution 0.01% in the prevention of cluster headaches during an episodic cluster headache period. Approximately 180 subjects (about 90 per treatment group),will be enrolled and randomized to double-blind treatment with either civamide nasal solution 0.01% or vehicle solution at approximately 50 study sites with about 2-5 subjects randomized per enrolling site.~This study consists of four periods beginning with a Screening Period, lasting for a minimum of 1 day to a maximum of 12 months, during which a subject previously diagnosed with episodic cluster headaches is not experiencing cluster headaches and is awaiting the onset of their next episodic cluster headache period and subsequent enrollment. The Screening Period is followed by a 31-day study, consisting of a 3-day Baseline Period which may begin with the onset of an episodic cluster headache period and ends on the day prior to initiating treatment (Day -1). Subjects return for Visit 2 (Day 1, Pre-Dose) and the Treatment Period begins, consisting of seven (7) days of double-blind treatment. The Treatment Period is immediately followed by a twenty-one (21) day Post-Treatment Observation Period.
The purpose of this study is to evaluate the safety and efficacy of intranasally administered civamide nasal solution in the prevention of cluster headaches during an episodic cluster headache period.