Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150735

Enrollment

580

Registered

2005-09-08

Start date

2002-06-30

Completion date

2005-07-31

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Epilepsy

Keywords

Monotherapy, epilepsy, Levetiracetam, Keppra.

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.

Interventions

DRUGLEVETIRACETAM

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Proportion of subjects with one year seizure freedom; time to first seizure; safety.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026