Pregabalin Versus Levetiracetam In Partial Seizures

Viatris

Status and phase

Completed

Phase 3

Conditions

Partial Seizures

Treatments

Drug: pregabalin

Drug: levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00537238

A0081157

Details and patient eligibility

About

This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Enrollment

509 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Exclusion criteria

Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.