Clinical trial NCT02209155: R-Verapamil for the Prophylaxis of Episodic Cluster Headache
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Episodic Cluster Headache
Lead sponsor: Center Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in the average daily frequency of attacks
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in the average daily frequency of attacks
timeFrame: 1 week
measure: Change in intensity of attacks
timeFrame: 2 weeks
measure: Change in duration of attacks
timeFrame: 2 weeks
measure: Change in consumption of abortive agents
timeFrame: 2 weeks
measure: Patient acceptability of treatment
timeFrame: 2 weeks
measure: Change in headache severity index
timeFrame: 2 weeks
measure: Change in Hit-6 disability score
timeFrame: 2 weeks
measure: R-verapamil and Placebo responders
timeFrame: 2 weeks
Other outcomes:
measure: Adverse events assessments
timeFrame: 2 weeks
Locations:
city: London
country: United Kingdom
facility: UCLH/UCL NIHR Clinical Research Facility
Study officials:
References: