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

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.

Study Overview

• Status: Terminated
• Conditions: Episodic Cluster Headache
• Intervention / Treatment: Drug: Placebo; Drug: R-verapamil 75 mg tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • UCLH/UCL NIHR Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: R-verapamil 75 mg tablet; 375 mg/day; one in the morning, two in the afternoon and two at bedtime daily	Drug: R-verapamil 75 mg tablet
Placebo Comparator: Placebo; one in the morning, two in the afternoon and two at bedtime daily	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the average daily frequency of attacks	2 weeks

Secondary Outcome Measures

Outcome 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
Patient acceptability of treatment	2 weeks
Change in headache severity index	2 weeks
Change in Hit-6 disability score	2 weeks
R-verapamil and Placebo responders	2 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events assessments	2 weeks

Collaborators and Investigators

• Sponsor: Center Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Verapamil
• Other Study ID Numbers: R-Verapamil-001