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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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Overall trial objectives:
The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of aura and migraine headache and so be effective as prophylactic treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tonabersat 40 mg daily |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonabersat | Drug | two tablets once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the mean number of aura attacks experienced between treatment groups | 12 week treatment period | |
| Difference in the mean number of migraine headache days between treatment groups | 12 week treatment period | |
| Incidence of adverse events | 12 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of headache days in each treatment period. | 12 week treatment period | |
| Mean number of auras followed by headache in each treatment period. | 12 week treatment period | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jes Olesen, MD | University of Copenhagen, Department of Neurology, Glostrup Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Centre, Department of Neurology, Glostrup Hospital | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine (second edition). Cephalalgia 2000; 20:765-86. Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products for the treatment of migraine, CPMP/EWP/788/01/Final. London, 17 December 2003. | ||
| Background | Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products for the treatment of migraine, CPMP/EWP/788/01/Final. London, 17 December 2003. | ||
| 19570717 | Result | Hauge AW, Asghar MS, Schytz HW, Christensen K, Olesen J. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study. Lancet Neurol. 2009 Aug;8(8):718-23. doi: 10.1016/S1474-4422(09)70135-8. Epub 2009 Jun 29. |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C118706 | tonabersat |
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| Drug |
two tablets once daily |
|
| Mean number of headache days in each month of treatment in each treatment period. |
| Mean monthly |
| Mean number of auras and/or migraine headache during each treatment period. | 12 week treatment period |
| Mean number of migraine headache attacks in each treatment period. | 12 week treatment period |
| Speed of effect of treatment. | First month for which difference between treatments identified |
| Mean monthly consumption of rescue medication. | Mean monthly |
| Mean duration of auras in each treatment period. | Mean over 12 week treatment period |
| Mean number of symptoms associated with auras in each treatment period. | 12 week treatment period |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |