At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 44 enrolled

Drug / intervention

Levetiracetamdrug

Likely dose

Levetiracetam 250 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.

Search/NCT01398956

NCT01398956Phase 3Completed

Compare CT.gov

An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures

UCB Pharma·interventional·Posted Jul 21, 2011·Updated Aug 15, 2017

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Epilepsy and Generalized Tonic-clonic Seizures. Completed, enrolled 44 participants across 32 sites.

Detailed Summary

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEpilepsy, Generalized Tonic-clonic Seizures

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

Enrollment StartJun 2011

First PostedJul 2011

Primary CompletionApr 2016

TodayJul 2026

First PostedJul 21, 2011

Enrollment StartJun 1, 2011

Primary CompletionApr 1, 2016

TodayJul 2, 2026

Enrollment to primary: 4.8 yearsPosted 14.9 years ago

Interventions

Levetiracetamdrug

formulation: tablet or dry syrup strength: 250 mg tablet, 500 mg tablet, dry syrup 50% dosage: Sb ≥16 years and ≥4 and \<16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and \<16 years (\<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day frequency: twice daily