At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 38 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Levetiracetam 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Arm, Multicenter Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
In Brief
A Phase 3 clinical trial evaluating Levetiracetam for Partial Seizures. Completed, enrolled 38 participants across 21 sites.
Detailed Summary
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Seizures
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionJun 2021
Study CompletionJul 2023
TodayJul 2026
First PostedNov 13, 2017
Enrollment StartNov 30, 2017
Primary CompletionJun 1, 2021
Study CompletionJul 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.6 years ago
Interventions
Levetiracetamdrug
levetiracetam dry syrup 50% for oral administration and levetiracetam solution for infusion (100 mg/mL)