An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Overview
- Phase
- Phase 3
- Intervention
- pregabalin
- Conditions
- Epilepsy
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completed the previous protocol and wish to continue to receive pregabalin.
- •Diagnosis of epilepsy with partial seizures
Exclusion Criteria
- •Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Arms & Interventions
1
Intervention: pregabalin
Outcomes
Primary Outcomes
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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
Time Frame: Baseline up to Week 28
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time Frame: 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.