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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018766-23 | EudraCT Number |
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This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGG492 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGG492 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. | 28 days | |
| Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36693 | United States | ||
| Johns Hopkins Hospital |
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|
| 12 weeks |
| Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.) | 10 weeks |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Epilepsy Care Specialists, S.C. | Milwaukee | Wisconsin | 53215 | United States |
| Novartis Investigative Site | Salzburg | A-5020 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigational Site | Vienna | 1130 | Austria |
| Novartis Investigative Site | Duffel | 2570 | Belgium |
| Novartis Investigative Site | Ottignies | 1340 | Belgium |
| Novartis Investigative Site | Sofia | 1113 | Bulgaria |
| Novartis Investigative Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Tallinn | 10617 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Bangalore | Karnataka | 560054 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400012 | India |
| Novartis Investigative Site | Dehli | New Delhi | 110002 | India |
| Novartis Investigative Site | Jaipur | 302004 | India |
| Novartis Investigative Site | Riga | 1002 | Latvia |
| Novartis Investigative Site | Riga | LV-1038 | Latvia |
| Novartis Investigative Site | Kaunas | 50009 | Lithuania |
| Novartis Investigative Site | Bucharest | 011635 | Romania |
| Novartis Investigative Site | Bucharest | 024092 | Romania |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
| D001927 | Brain Diseases |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591013 | selurampanel |
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