Episodic Cluster Headache Clinical Trial
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
Verified date | April 2018 |
Source | Center Laboratories, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | UCLH/UCL NIHR Clinical Research Facility | London |
Lead Sponsor | Collaborator |
---|---|
Center Laboratories, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events assessments | 2 weeks | ||
Primary | Change in the average daily frequency of attacks | 2 weeks | ||
Secondary | Change in the average daily frequency of attacks | 1 week | ||
Secondary | Change in intensity of attacks | 2 weeks | ||
Secondary | Change in duration of attacks | 2 weeks | ||
Secondary | Change in consumption of abortive agents | 2 weeks | ||
Secondary | Patient acceptability of treatment | 2 weeks | ||
Secondary | Change in headache severity index | 2 weeks | ||
Secondary | Change in Hit-6 disability score | 2 weeks | ||
Secondary | R-verapamil and Placebo responders | 2 weeks |
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