Status:
TERMINATED
R-Verapamil for the Prophylaxis of Episodic Cluster Headache
Lead Sponsor:
Center Laboratories, Inc.
Conditions:
Episodic Cluster Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02209155
Start Date
November 1 2013
End Date
March 1 2018
Last Update
April 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLH/UCL NIHR Clinical Research Facility
London, United Kingdom, NW1 2BU