EUCTR2012-003729-62-GB
Active, not recruiting
Phase 1
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 - R-Verapamil in the Prophylaxis of Episodic Cluster Headache V.1
CENTER LABORATORIES, INC0 sites30 target enrollmentOctober 11, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CENTER LABORATORIES, INC
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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