Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
- Registration Number
- NCT00596466
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Completed the previous protocol and wish to continue to receive pregabalin.
- Diagnosis of epilepsy with partial seizures
- Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 pregabalin -
- Primary Outcome Measures
Name Time Method Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Week 28 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.
Seizure Frequency Baseline up to Week 28 Number of Participants With Laboratory Test Values of Potential Clinical Importance Baseline up to Week 28 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇦Odessa, Ukraine