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Design
Randomised {allocation concealed*},
blinded {clinicians, patients, and outcome assessors*},
placebo controlled trial with 2 week follow up.
Setting
3 outpatient clinics in Italy.
Patients
30 adults between 18 and 60 years of age (mean age 44 y, 90% men) who were outpatients and had a diagnosis of episodic cluster headache (International Headache Society criteria) with
1 previous cluster period lasting
1 month and who had been in a cluster period for
10 days and had an expected duration of the remainder of the cluster period of
20 days. Exclusion criteria were liver or kidney disease, cardiopathological findings contraindicating verapamil use, psychiatric disorder, use of antidepressants or antipsychotics, drug or alcohol abuse, or previous adynamic ileus. Follow up was 100%.
Intervention
After a 5 day run-in period, patients were allocated to verapamil, 120 mg 3 times/day (n=15), or placebo, 3 times/day (n=15), for 2 weeks.
Main outcome measures
Self reported frequency of cluster headache attacks
Robert Badgett, MD
University of Texas Health Sciences Center San Antonio, Texas, USA
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