Episodic Cluster Headache
Conditions
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.
Interventions
DRUGR-verapamil 75 mg tablet
DRUGPlacebo
Sponsors
Center Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the average daily frequency of attacks | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in the average daily frequency of attacks | 1 week |
| Change in intensity of attacks | 2 weeks |
| Change in duration of attacks | 2 weeks |
| Change in consumption of abortive agents | 2 weeks |
| Change in headache severity index | 2 weeks |
| Change in Hit-6 disability score | 2 weeks |
| R-verapamil and Placebo responders | 2 weeks |
| Patient acceptability of treatment | 2 weeks |
Other
| Measure | Time frame |
|---|---|
| Adverse events assessments | 2 weeks |
Countries
United Kingdom
Outcome results
None listed