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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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