At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 660 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 150-600 mg/day (BID) or Lamotrigine 100-500 mg/day (BID)AI-extracted
Key inclusion· 3
- ✓Diagnosed with partial epilepsy
- ✓At least 2 partial seizures in the past year
- ✓One seizure within the past 6 months
Key exclusion· 2
- ✕Treatable causes of seizures (metabolic, neoplastic, or active infectious etiology)
- ✕Primary generalized seizures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 20, 2006·Updated Jan 28, 2021
In Brief
A Phase 3 clinical trial evaluating Pregabalin and Lamotrigine for Epilepsy, Partial. Completed, enrolled 660 participants across 102 sites in 29 countries.
Detailed Summary
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial
CountriesBelgium, Bulgaria, China, Colombia, Czechia, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Portugal, Romania, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2006
Enrollment StartAug 2006
Primary CompletionDec 2009
Study CompletionApr 2010
TodayJul 2026
First PostedJan 20, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.4 years ago
Interventions
Pregabalindrug
dose 150-600 mg/day given BID
Lamotriginedrug
dose 100-500 mg/day given BID