R-Verapamil for the Prophylaxis of Episodic Cluster Headache
Phase 2
Terminated
- Conditions
- Episodic Cluster Headache
- Interventions
- Drug: R-verapamil 75 mg tabletDrug: Placebo
- Registration Number
- NCT02209155
- Lead Sponsor
- Center Laboratories, Inc.
- 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-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R-verapamil 75 mg tablet R-verapamil 75 mg tablet 375 mg/day; one in the morning, two in the afternoon and two at bedtime daily Placebo Placebo one in the morning, two in the afternoon and two at bedtime daily
- Primary Outcome Measures
Name Time Method Change in the average daily frequency of attacks 2 weeks
- Secondary Outcome Measures
Name Time Method Change in the average daily frequency of attacks 1 week Patient acceptability of treatment 2 weeks Change in duration of attacks 2 weeks Change in headache severity index 2 weeks Change in Hit-6 disability score 2 weeks R-verapamil and Placebo responders 2 weeks Change in intensity of attacks 2 weeks Change in consumption of abortive agents 2 weeks
Trial Locations
- Locations (1)
UCLH/UCL NIHR Clinical Research Facility
🇬🇧London, United Kingdom