Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

Pfizer

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Complex Partial; Epilepsies, Partial

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143143

1008-000-164

Details and patient eligibility

About

The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
• Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
• Be currently taking 1 to 3 AEDs.

Exclusion criteria

• Have a treatable cause of seizures
• Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)