E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
- Epilepsy
- Generalized Tonic-Clonic Seizures
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015037 |
E.1.2 | Term | Epilepsy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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).
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of Levetiracetam (LEV) treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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
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E.4 | Principal exclusion criteria |
- 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
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E.5 End points |
E.5.1 | 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)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- The percentage reduction in generalized tonic-clonic seizure frequency per week from the combined baseline over the evaluation period
- 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
- 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
- Generalized tonic-clonic seizure freedom over the evaluation period
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- From Baseline to Evaluation Period (Week 12 to Week 28)
- From Baseline to Week 28
- From Baseline to Evaluation Period (Week 12 to Week 28)
- Evaluation Period (Week 12 to Week 28)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |