Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150787

Enrollment

250

Registered

2005-09-08

Start date

2003-07-31

Completion date

2005-11-30

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

Epilepsy, Tonic-clonic

Keywords

Monotherapy, epilepsy, Levetiracetam, Keppra

Brief summary

A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

Interventions

DRUGLEVETIRACETAM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Inclusion criteria

* Subjects with a confirmed diagnosis of epilepsy. * Subjects having experienced in the past 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 * Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion criteria

* Need for an additional AED.

Design outcomes

Primary

Measure	Time frame
Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026