Epilepsy MedDRA version: 19.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Lamictal
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: LAMOTRIGINE
CAS Number: 84057-84-1
Other descriptive name: LAMOTRIGINE
Concentration unit: mg milligram(s)
Concentr
Sponsors
GlaxoSmithKline K.K. (GSK)
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
Exclusion criteria: Please see inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) ;Timepoint(s) of evaluation of this end point: - Up to Week 30 - Weeks 7 to 30 | — |
Countries
Japan, Korea, Republic of
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed