R-Verapamil for the Prophylaxis of Episodic Cluster Headache

Inclusion Criteria

• •Healthy man or woman between the ages of 18 and 65
• •In good health as determined by medical history and medical examination
• •Has a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
• •Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience at least 7 attacks/week during the run-in baseline period
• •Subjects must have a typical cluster period lasting at least 1 month. Subjects must be present in active cluster period and the expected remaining duration of the cluster cycle must be at least 3 weeks from Baseline Day 1 visit
• •Able to differentiate other headache types from cluster headaches
• •Is using or agrees to use a medically acceptable form of contraception(female of child-bearing potential)
• •Negative urine pregnancy test prior to study entry(female of child-bearing potential)
• •Concomitant medication that, in the opinion of the investigator and the patient's general practitioner(GP), do not pose an unacceptable risk based upon the prescribing information for verapamil
• •Able to understand and comply with all study requirements
• •Written informed consent