Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

UCB

Status and phase: Completed; Phase 3

Conditions: Generalized Epilepsy

Treatments: Drug: LEVETIRACETAM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150735

N01061

Details and patient eligibility

About

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.