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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-005065-64 |
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This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGG492 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational new drug, company code: BGG492 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure:An efficacy of investing. drug vs. Pcb in reducing the seizure rate when administered orally for up to 9days (during titration monotherapy)in pts. with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy surgery. | 9 days | |
| Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures |
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Berlin | Germany | ||||
| Novartis Investigator Site |
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|
| 9 days |
| Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures. | 9 days |
| Bielefeld |
| Germany |
| Novartis Investigator Site | Bonn | Germany |
| Novartis Investigator Site | Erlangen | Germany |
| Novartis Investigator Site | Freiburg im Breisgau | Germany |
| Novartis Investigator Site | Munich | Germany |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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