CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 37 enrolled
Drug / intervention
Rufinamide +1 moredrug
Likely dose
Rufinamide 45 mg/kgfrom 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.

Search/NCT01405053
NCT01405053Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

Eisai Inc.·interventional·Posted Jul 29, 2011·Updated Aug 6, 2019

In Brief

A Phase 3 clinical trial evaluating Rufinamide and Any other approved Antiepileptic Drug for Lennox-Gastaut Syndrome. Completed, enrolled 37 participants across 47 sites in 7 countries.

Detailed Summary

This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLennox-Gastaut Syndrome
CountriesCanada, France, Greece, Italy, Poland, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2011
Enrollment StartJun 16, 2011
Primary CompletionNov 2, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.9 years ago

Interventions

Rufinamidedrug

Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs)

Any other approved Antiepileptic Drugdrug

Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)