R-Verapamil for the Prophylaxis of Episodic Cluster Headache

NCT02209155 | Terminated Phase 2

• 1 other identifier: R-Verapamil-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Episodic Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Change in the average daily frequency of attacks

  2 weeks

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Adverse events assessments

  2 weeks

Study Arms (2)

R-verapamil 75 mg tablet

ACTIVE COMPARATOR

375 mg/day; one in the morning, two in the afternoon and two at bedtime daily

Drug: R-verapamil 75 mg tablet

Placebo

PLACEBO COMPARATOR

one in the morning, two in the afternoon and two at bedtime daily

Drug: Placebo

Interventions

R-verapamil 75 mg tablet DRUG

R-verapamil 75 mg tablet

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center Laboratories, Inc.: lead

Study Sites (1)

UCLH/UCL NIHR Clinical Research Facility

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Verapamil; Tablets

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

GB (1)