Double blind, randomized, historical control study of the safety and efficacy of Eslicarbazepine Acetate Monotherapy in subjects with partial epilepsy not well controlled by current antiepileptic drugs
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- STATUS
- Recruiting
Summary
Double blind, randomized, historical control study of the safety and efficacy of Eslicarbazepine Acetate Monotherapy in subjects with partial epilepsy not well controlled by current antiepileptic drugs
Description
This research study will examine the safety and efficacy of Eslicarbazepine Acetate therapy at a dose of 1600 mg/day in subjects with partial epilepsy not well controlled on their current anti epileptic regimen.
Patient Inclusion Criteria:
- 16 -70 years of age
- Documented diagnosis of epilepsy w/EEG done in prior 10 years
- At least 4 partial-onset seizures in the prior 4 weeks
- Current treatment with 1 or 2 antiepileptic drugs (stable dose for 1 mo)
- Documented CT or MRI scan in prior 10 years showing abnormality
- At least 4 partial onset seizures during 8 wks prior to screening
Patient Exclusion Criteria:
- Simple partial seizures w/no motor symptomology
- Primary generalized seizures
- Seizures secondary to medical illness, disorders or drug abuse
- Status epilepticus w/in 2 years prior to screening
- Seizures occurring in a cluster pattern
- Taking more than 2 antiepileptic drugs
- Progressive CNS lesion or progressive encephalopathy
Details
| Condition | Seizure Disorders |
|---|---|
| Clinical Study Identifier | TX135192 |
| Last Modified on | 8 November 2020 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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