Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

Phase 3

Completed

• Conditions: Generalized Epilepsy

• Registration Number: NCT00150735
• Lead Sponsor: UCB Pharma

Brief Summary

A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2010-07
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

• Subjects with newly or recently diagnosed epilepsy having experienced 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. The discrimination between IC and IIE is not requested for inclusion.
• Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
• Subjects with a confirmed diagnosis of epilepsy.
• Male/female subjects (≥16 years).

Exclusion Criteria

• History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
• History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. < 20 minutes, with or without function regained between 2 ictal events.
• History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with one year seizure freedom; time to first seizure; safety.