Status:

COMPLETED

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

Lead Sponsor:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Conditions:

Epilepsy

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 (1...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT00288639

Start Date

December 1 2005

End Date

December 1 2007

Last Update

January 22 2021

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Pfizer Investigational Site

Athens, Greece, 11526

2

Pfizer Investigational Site

Athens, Greece, 11527

3

Pfizer Investigational Site

Heraklio, Greece, 71110

4

Pfizer Investigational Site

Mesogion, Athen, Greece, 15125