Pregabalin Epilepsy Add-On Trial

Viatris

Status and phase

Completed

Phase 3

Conditions

Partial Seizures

Treatments

Drug: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141258

A0081079

Details and patient eligibility

About

To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

Enrollment

178 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures

Exclusion criteria

Have a treatable cause of seizures
Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)