Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

Viatris

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00288639

A0081088

Details and patient eligibility

About

The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
• Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion criteria

• AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
• Having absences seizures
• Having had status epileptics within the year prior to inclusion
• Having a progressive neurological or systematic disorder
• Having known significant renal or hepatic dysfunction

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)