E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 19.0 |
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 |
|
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 and safety of lamotrigine monotherapy [initial dose 25 mg/day, maintenance dose 200 mg/day (the dose can be increased up to 400 mg/day)] administered orally once daily (the dose exceeding 200 mg/day can be administered in two divided doses) in patients with newly diagnosed epilepsy and those with recurrent epilepsy (currently untreated) in Japan and South Korea. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects with newly diagnosed epilepsy or recurrent epilepsy which is untreated, having partial seizures (including secondarily generalization) or generalized tonic-clonic seizures; subjects having a confident diagnosis of epilepsy uncomplicated by pseudoseizures (psychogenic nonepileptic seizures); subjects having had at least 2 seizures in the previous 6 months with at least 1 seizure in the previous 3 months; outpatients aged ≥16 years at the time of obtaining consent who are able to write a seizure diary; subjects having no other seizure types than partial seizures or generalized tonic-clonic seizures with or without myoclonus; subjects having no status epilepticus within the 6 months prior to the start of study treatment; subjects without a history of treatment with antiepileptic drugs (≥2 weeks) during 6 months before the start of treatment with the investigational product; and subjects without a history of treatment with lamotrigine. |
|
E.4 | Principal exclusion criteria |
Please see inclusion criteria. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Seizure free rate in the maintenance phase (across seizure types and by seizure type): [Number of subjects who complete the study and who have not experienced seizures in the maintenance phase / Number of subjects who receive the investigational product] |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Time to withdrawal/dropout from the study (across seizure types and by seizure type within 6 months prior to the start of the study)
- Time to first seizure in the maintenance phase (across seizure types and by seizure type)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Up to Week 30
- Weeks 7 to 30 |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 |
|
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
|
|
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 4 |