At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 54 enrolled
Drug / intervention
Rufinamidedrug
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.
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
In Brief
A Phase 3 clinical trial evaluating Rufinamide for Lennox-Gastaut Syndrome. Completed, enrolled 54 participants across 23 sites.
Detailed Summary
To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLennox-Gastaut Syndrome
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartNov 2010
Primary CompletionAug 2013
TodayJul 2026
First PostedJun 28, 2010
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.0 years ago
Interventions
Rufinamidedrug
The target dosage is approximately 45 mg/kg/day, taken orally twice a day.