Official Title: “A Multicenter, Double-Blind, Randomized, Parallel Group, Positive-Controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-Clonic Seizures”

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.

Study Type: Interventional

Study Design: Non-Randomized, Double-Blind, Active Control, Parallel Assignment

Study Primary Completion Date: July 2005

Intervention(s) in this Clinical Trial

• Drug: LEVETIRACETAM

Primary Measures

• 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 Measures

• Proportion of subjects with one year seizure freedom; time to first seizure; safety.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Françoise Tonner, M.D Study Director Unaffiliated  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150735

Study ID Number: N01061

ClinicalTrials.gov Identifier: NCT00150735

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines