A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized 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
- EUCTR2014-004401-32-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
- 361
- An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE 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 and during the combined baseline period
Are the trial subjects under 18? yes
Number of subjects for this age range: 27
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 329
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5
- 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 imagining features
- A history of convulsive or non-convulsive 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 of Levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged = 16 years with uncontrolled generalized tonic-clonic seizures despite treatment with 1 or 2 antiepileptic drug(s). <br>;Secondary Objective: To evaluate the safety and tolerability of Levetiracetam (LEV) treatment <br>;Primary end point(s): Percentage reduction from the Combined Baseline (a 4-week Retrospective Baseline + 4-week Prospective Baseline) in the generalized tonic-clonic seizure frequency per week over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods) <br>;Timepoint(s) of evaluation of this end point: From Baseline to Week 28 <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The percentage reduction in generalized tonic-clonic seizure frequency per week from the combined baseline 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 (the proportion of subjects with 50 % or more reduction from the combined baseline in the frequency of generalized tonic-clonic seizures) during the evaluation period <br>- Generalized tonic-clonic seizure freedom over the evaluation period <br>;Timepoint(s) of evaluation of this end point: - From Baseline to Evaluation Period (Week 12 to Week 28) <br>- From Baseline to Week 28 <br>- From Baseline to Evaluation Period (Week 12 to Week 28)<br>- Evaluation Period (Week 12 to Week 28) <br>