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To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Enzyme-inducing placebo TID |
|
| 2 | Experimental | Enzyme-inducing Talampanel 35 mg TID |
|
| 3 | Experimental | Enzyme-inducing TLP 50mg TID |
|
| 4 | Placebo Comparator | Non-enzyme-inducing placebo TID |
|
| 5 | Experimental | Non-enzyme-inducing TLP 25mg TID |
|
| 6 | Experimental | Non-enzyme-inducing TLP 35mg TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talampanel | Drug | Non-enzyme-inducing TLP 35mg TID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in frequency of partial seizures | Change in frequency of recognizable seizures as measured by entries in a seizure diary | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of seizure-free days and percent responders | A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline | 12 weeks |
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Inclusion Criteria:
Exclusion:
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C085266 | talampanel |
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| Drug |
Enzyme-inducing placebo TID |
|
| Talampanel | Drug | Enzyme-inducing Talampanel 35 mg TID |
|
| Talampanel | Drug | Enzyme-inducing TLP 50mg TID |
|
| Placebo | Drug | Non-enzyme-inducing placebo TID |
|
| Talampanel | Drug | Non-enzyme-inducing TLP 25mg TID |
|