At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Pregabalin (dose determined by escalating dose protocol; specific dose not stated)AI-extracted
Key inclusion· 2
- ✓Partial onset seizures, incompletely controlled on 1-3 medications
- ✓At least 1 seizure per 28 days on average
Key exclusion· 2
- ✕Primary generalized seizures
- ✕Progressive CNS pathology
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Feb 19, 2007·Updated Feb 11, 2021
In Brief
A Phase 2 clinical trial evaluating Placebo and Pregabalin for Epilepsies, Partial. Completed, enrolled 65 participants across 18 sites in 3 countries.
Detailed Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsies, Partial
CountriesMexico, South Korea, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartApr 2007
Primary CompletionNov 2012
TodayJul 2026
First PostedFeb 19, 2007
Enrollment StartApr 1, 2007
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.4 years ago
Interventions
Placebodrug
Placebo
Pregabalindrug
Orally-administered pregabalin