Phase 3
N=75
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00596466 ↗Enrolled (actual)
75
Serious AEs
4.1%
Results posted
Sep 2012
Primary outcome: Primary: Seizure Frequency
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seizure Frequency |
— | — |
| PRIMARY Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) |
30; 3 | — |
| PRIMARY Number of Participants With Laboratory Test Values of Potential Clinical Importance |
17 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00596466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.