Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures|
- Seizure Frequency [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
- Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: Yes ]Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
- Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: Yes ]Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
|Study Start Date:||April 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596466
Show 44 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|