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

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Diagnosis of epilepsy with partial seizures.

• Males or females, age 18 years or older.

• Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.

• Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Exclusion Criteria:

• Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.

• Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.

• Primary generalized epilepsy or status epilepticus within the previous year.