Trials Sponsors Conditions Drugs Pricing

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
+3 more secondary outcomes

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 tabletDrug

R-verapamil 75 mg tablet

PlaceboDrug

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Center Laboratories, Inc.
Industrylead

Study Sites (1)

UCLH/UCL NIHR Clinical Research Facility

London, NW1 2BU, United Kingdom

MeSH Terms

Conditions

Cluster Headache

Interventions

VerapamilTablets

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Enrollment

1 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

R-Verapamil for the Prophylaxis of Episodic Cluster Headache

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (1)

Study Arms (2)

R-verapamil 75 mg tablet

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (1)

Study Arms (2)

R-verapamil 75 mg tablet

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations