A multi-center, uncontrolled, open-label, evaluation of lamotrigine monotherapy in adult subjects with newly diagnosed epilepsy or recurrent epilepsy (currently untreated).
- Conditions
- EpilepsyMedDRA version: 19.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004878-15-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline K.K. (GSK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 65
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 7
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13
Please see inclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable ;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];Timepoint(s) of evaluation of this end point: Weeks 7-30;Main Objective: 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.
- Secondary Outcome Measures
Name Time Method 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)<br>- Time to first seizure in the maintenance phase (across seizure types and by seizure type)<br>;Timepoint(s) of evaluation of this end point: - Up to Week 30<br>- Weeks 7 to 30