R-Verapamil for the Prophylaxis of Episodic Cluster Headache

• Status: Terminated
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center Laboratories, Inc.
• Treatments: Verapamil

Criteria

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 efficacy and tolerability

• Use of any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication

• The concomitant use of beta blockers

• The consumption of grapefruit juice

• Allergic to or has shown hypersensitivity to verapamil or agents similar to verapamil

• Abuses opioids or has a history of significant drug or alcohol abuse within the past year as determined by investigator

• Has participated in an investigational drug trial in the 30 days prior to the screening visit

• Has liver or kidney disease

• Has a cardiopathology contraindicating verapamil administration

• Subjects with previous adynamic ileus.

• Subjects with chronic cluster headache

• Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion