R-Verapamil for the Prophylaxis of Episodic Cluster Headache

Episodic Cluster Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02209155
• Other study ID #: R-Verapamil-001
• Status: Terminated
• Phase: Phase 2
• First received: August 4, 2014
• Last updated: April 9, 2018
• Start date: November 2013
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Center Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Episodic Cluster Headache
• Headache

Intervention

Drug:
• R-verapamil 75 mg tablet

• Placebo

Locations

Country	Name	City	State
United Kingdom	UCLH/UCL NIHR Clinical Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Center Laboratories, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events assessments		2 weeks
Primary	Change in the average daily frequency of attacks		2 weeks
Secondary	Change in the average daily frequency of attacks		1 week
Secondary	Change in intensity of attacks		2 weeks
Secondary	Change in duration of attacks		2 weeks
Secondary	Change in consumption of abortive agents		2 weeks
Secondary	Patient acceptability of treatment		2 weeks
Secondary	Change in headache severity index		2 weeks
Secondary	Change in Hit-6 disability score		2 weeks
Secondary	R-verapamil and Placebo responders		2 weeks