Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

UCB Pharma250 enrolled

Overview

A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

250

Conditions

Epilepsy, Tonic-clonic

Interventions

LEVETIRACETAMDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with a confirmed diagnosis of epilepsy. * Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures * Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial. Exclusion Criteria: * Need for an additional AED.

Outcomes

Primary Outcomes

Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs

Data from ClinicalTrials.gov

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