R-Verapamil for the Prophylaxis of Episodic Cluster Headache

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

NCT02209155•Center Laboratories, Inc.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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
+1 more criteria

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
+3 more criteria

Locations (1)

UCLH/UCL NIHR Clinical Research Facility

London, United Kingdom

Key Dates

Start Date

November 1, 2013

Primary Completion Date

March 1, 2018

Completion Date

March 1, 2018

Last Updated

April 11, 2018

Enrollment

ACTUAL participants

Conditions

Episodic Cluster Headache

Interventions

R-verapamil 75 mg tablet

DRUG

Placebo

DRUG

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

NCT02945046

Episodic Cluster Headache

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COMPLETEDPHASE3

A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

NCT00033839

Episodic Cluster Headache

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UNKNOWNPHASE4

Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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