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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-verapamil 75 mg tablet | Active Comparator | 375 mg/day; one in the morning, two in the afternoon and two at bedtime daily |
|
| Placebo | Placebo Comparator | one in the morning, two in the afternoon and two at bedtime daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-verapamil 75 mg tablet | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average daily frequency of attacks | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average daily frequency of attacks | 1 week | |
| Change in intensity of attacks | 2 weeks | |
| Change in duration of attacks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events assessments | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLH/UCL NIHR Clinical Research Facility | London | NW1 2BU | United Kingdom |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| 2 weeks |
| Change in consumption of abortive agents | 2 weeks |
| Patient acceptability of treatment | 2 weeks |
| Change in headache severity index | 2 weeks |
| Change in Hit-6 disability score | 2 weeks |
| R-verapamil and Placebo responders | 2 weeks |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |