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

Center Laboratories, Inc.1 site in 1 country1 target enrollmentNovember 2013

ConditionsEpisodic Cluster Headache

InterventionsR-verapamil 75 mg tablet Placebo

DrugsR-verapamil 75 mg tablet Placebo

Overview

Phase: Phase 2
Intervention: R-verapamil 75 mg tablet
Conditions: Episodic Cluster Headache
Sponsor: Center Laboratories, Inc.
Enrollment: 1
Locations: 1
Primary Endpoint: Change in the average daily frequency of attacks
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

March 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Center Laboratories, Inc.

Responsible Party

Sponsor

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

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