This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.
Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1
UCLH/UCL NIHR Clinical Research Facility
London, United Kingdom
Change in the average daily frequency of attacks
Time frame: 2 weeks
Change in the average daily frequency of attacks
Time frame: 1 week
Change in intensity of attacks
Time frame: 2 weeks
Change in duration of attacks
Time frame: 2 weeks
Change in consumption of abortive agents
Time frame: 2 weeks
Patient acceptability of treatment
Time frame: 2 weeks
Change in headache severity index
Time frame: 2 weeks
Change in Hit-6 disability score
Time frame: 2 weeks
R-verapamil and Placebo responders
Time frame: 2 weeks
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