Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

Phase 3

Completed

• Conditions: Epilepsy, Tonic-clonic

• Registration Number: NCT00150787
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2009-09
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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