Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Tonic-clonic

Treatments: Drug: LEVETIRACETAM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150787

N01093

Details and patient eligibility

About

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

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.