R-Verapamil for the Prophylaxis of Episodic Cluster Headache

• ClinicalTrials.gov Identifier: NCT02209155
• Recruitment Status: Terminated
• First Posted: August 5, 2014
• Last Update Posted: April 11, 2018
• Sponsor: Center Laboratories, Inc.
• Information provided by (Responsible Party): Center Laboratories, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Episodic Cluster Headache	Drug: R-verapamil 75 mg tablet; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: November 2013
• Actual Primary Completion Date: March 2018
• Actual Study Completion Date: March 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in the average daily frequency of attacks [ Time Frame: 2 weeks ]

Secondary Outcome Measures :

1. Change in the average daily frequency of attacks [ Time Frame: 1 week ]
2. Change in intensity of attacks [ Time Frame: 2 weeks ]
3. Change in duration of attacks [ Time Frame: 2 weeks ]
4. Change in consumption of abortive agents [ Time Frame: 2 weeks ]
5. Patient acceptability of treatment [ Time Frame: 2 weeks ]
6. Change in headache severity index [ Time Frame: 2 weeks ]
7. Change in Hit-6 disability score [ Time Frame: 2 weeks ]
8. R-verapamil and Placebo responders [ Time Frame: 2 weeks ]

Other Outcome Measures:

1. Adverse events assessments [ Time Frame: 2 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• 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

Contacts and Locations

Locations

United Kingdom

UCLH/UCL NIHR Clinical Research Facility

London, United Kingdom, NW1 2BU

Sponsors and Collaborators

Center Laboratories, Inc.

More Information

• Responsible Party: Center Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT02209155
• Other Study ID Numbers: R-Verapamil-001
• First Posted: August 5, 2014
• Last Update Posted: April 11, 2018
• Last Verified: April 2018

Additional relevant MeSH terms:

Cluster Headache; Headache; Pain; Neurologic Manifestations; Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Verapamil; Anti-Arrhythmia Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents