R-Verapamil for the Prophylaxis of Episodic Cluster Headache

Center Laboratories

Status and phase

Terminated

Phase 2

Conditions

Episodic Cluster Headache

Treatments

Drug: R-verapamil 75 mg tablet

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02209155

R-Verapamil-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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