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R-Verapamil for the Prophylaxis of Episodic Cluster Headache

Primary Purpose

Episodic Cluster Headache

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
R-verapamil 75 mg tablet
Placebo
Sponsored by
Center Laboratories, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Episodic Cluster Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLH/UCL NIHR Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

R-verapamil 75 mg tablet

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the average daily frequency of attacks

Secondary Outcome Measures

Change in the average daily frequency of attacks
Change in intensity of attacks
Change in duration of attacks
Change in consumption of abortive agents
Patient acceptability of treatment
Change in headache severity index
Change in Hit-6 disability score
R-verapamil and Placebo responders

Full Information

First Posted
August 4, 2014
Last Updated
April 9, 2018
Sponsor
Center Laboratories, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02209155
Brief Title
R-Verapamil for the Prophylaxis of Episodic Cluster Headache
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Laboratories, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Cluster Headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-verapamil 75 mg tablet
Arm Type
Active Comparator
Arm Description
375 mg/day; one in the morning, two in the afternoon and two at bedtime daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one in the morning, two in the afternoon and two at bedtime daily
Intervention Type
Drug
Intervention Name(s)
R-verapamil 75 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in the average daily frequency of attacks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in the average daily frequency of attacks
Time Frame
1 week
Title
Change in intensity of attacks
Time Frame
2 weeks
Title
Change in duration of attacks
Time Frame
2 weeks
Title
Change in consumption of abortive agents
Time Frame
2 weeks
Title
Patient acceptability of treatment
Time Frame
2 weeks
Title
Change in headache severity index
Time Frame
2 weeks
Title
Change in Hit-6 disability score
Time Frame
2 weeks
Title
R-verapamil and Placebo responders
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Adverse events assessments
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UCLH/UCL NIHR Clinical Research Facility
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

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R-Verapamil for the Prophylaxis of Episodic Cluster Headache

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