Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

Viatris

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596466

A0081160

Details and patient eligibility

About

This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed the previous protocol and wish to continue to receive pregabalin.
• Diagnosis of epilepsy with partial seizures

Exclusion criteria

• Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

1

Experimental group

Treatment:

Drug: pregabalin