Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

Viatris

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Partial

Treatments: Drug: Lamotrigine; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00280059

A0081046

Details and patient eligibility

About

The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

Enrollment: 660 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.

Exclusion criteria

• Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
• Primary generalized seizures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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660 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Pregabalin

2

Active Comparator group

Treatment:

Drug: Lamotrigine