R-Verapamil for the Prophylaxis of Episodic Cluster Headache (NCT02209155) | Clinical Trial Compass
TerminatedPhase 2
R-Verapamil for the Prophylaxis of Episodic Cluster Headache
United Kingdom1 participantsStarted 2013-11
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
Exclusion Criteria:
* Women who are pregnant or lactating
* Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of effi…