A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
- Conditions
- - Epilepsy - Generalized Tonic-clonic SeizuresMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-004382-25-Outside-EU/EEA
- Lead Sponsor
- CB Japan Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 15
- An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
- A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
- Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
- Diagnosis of Lennox-Gastaut Syndrome
- Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
- A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of Levetiracetam (LEV) dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric subjects aged = 4 to < 16 years with uncontrolled generalized tonic-clonic (GTC) seizures, despite treatment with 1 or 2 Antiepileptic Drugs (AEDs). <br><br>;Secondary Objective: Not applicable;Primary end point(s): The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) <br>;Timepoint(s) of evaluation of this end point: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period <br>- Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period <br>- Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period <br>- Generalized Tonic-clonic Seizure Freedom Over the Treatment Period <br>- Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period <br>;Timepoint(s) of evaluation of this end point: - From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) <br>- From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) <br>- Treatment Period (Week 0 to Week 24) <br>- Evaluation Period (Week 4 to Week 24) <br>