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R-Verapamil for the Prophylaxis of Episodic Cluster Headache

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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



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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209155


Locations
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United Kingdom
UCLH/UCL NIHR Clinical Research Facility
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Center Laboratories, Inc.
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Responsible Party: Center Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02209155    
Other Study ID Numbers: R-Verapamil-001
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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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