Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prevention of Episodic Cluster Headache

Phase 1

• Conditions: Episodic Cluster Headache; MedDRA version: 15.0Level: PTClassification code 10059133Term: Cluster headacheSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003729-62-GB
• Lead Sponsor: CENTER LABORATORIES, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-11
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Participants will be healthy men and women between the ages of 18 and 65
•Participants in good health as determined by medical history and medical examination including vital signs and ECG. Serum biochemistry and hematology need to be normal
•Participants with a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
•Participants must have a lifetime prevalence of at least 2 prior cluster bouts
•Participants must experience at least 7 attacks/week during the run-in baseline period
•Participants must have a typical cluster period lasting at least 1 month. Subjects must present in active cluster period and the expected remaining duration of the cluster bout must be at least 3 weeks from Baseline Day 1 visit
•Participants with other headache types are eligible provided the subject is able to differentiate these headaches from cluster headaches
•Participants are using or agree to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
•Participants have a negative urine pregnancy test prior to study entry, if female of child-bearing potential
•Participants is able to understand and comply with all study requirements
•Participants provides written informed consent prior to any screening procedures being conducted

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Women who are pregnant or lactating
•Participants who, in the investigators opinion, have a history of 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 during this trial
•Participants using any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication
•Participants who are allergic to or have shown hypersensitivity to verapamil or agents similar to verapamil
•Participants who abuse opioids or have a history of significant drug or alcohol abuse within the past year as determined by investigator
•Participants who have participated in an investigational drug trial in the 30 days prior to the screening visit
•Participants with liver or kidney disease
•Participants with cardiopathology contraindicating verapamil administration (second or third grade atrioventricular block, sinoatrial block, sinus node syndrome, heart rate <50/minute, or systolic blood pressure <90 mm Hg)
•Participants with previous adynamic ileus
•Participants with chronic cluster headache
•Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified