Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

Condition(s) targeted: Generalized Epilepsy

Intervention: LEVETIRACETAM (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB

Official(s) and/or principal investigator(s):
Françoise Tonner, M.D, Study Director, Affiliation: Unaffiliated

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.

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

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

Primary outcome: 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: Proportion of subjects with one year seizure freedom; time to first seizure; safety.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: June 2002
Ending date: July 2005
Last updated: March 7, 2008