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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    Recruiting
Updated on 8 November 2020

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
Clinical Study IdentifierTX135192
Last Modified on8 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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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