Epilepsy
Conditions
Interventions
Trade Name: Lamictal XR,Lamictal,LAMICTIN
Product Code: BW430C
Pharmaceutical Form: Chewable/dispersible tablet
INN or Proposed INN: LAMOTRIGINE
Other descriptive name: LAMOTRIGINE
Concentration unit:
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Epilepsy with partial seizures - Tonic clonic seizures - Generalized seizures of Lennox-Gastaut - Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug. - Concurrent AEDs: Subjects taking concurrent VPA. Are the trial subjects under 18? yes Number of subjects for this age range: 57 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous participation in a study of Lamictal - Known hypersensitivity to any drugs - Pregnant women - nursing mothers - women who may be pregnant - women contemplating pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide confidence in the safety of LTG, as measured by the incidence of rash (including SJS and any other serious drug eruption) in the first 8 weeks of treatment, in Japanese patients with epilepsy when administered at the same starting doses and with the same dose escalation method as recommended overseas for patients taking VPA.;Secondary Objective: Not applicable ;Primary end point(s): Incidence of rash (including SJS and any other serious drug eruption) in the first 8 weeks of treatment in subjects taking VPA.;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A percent reduction in seizure frequency (all seizure types) during the maintenance phase compared to pre-treatment.;Timepoint(s) of evaluation of this end point: 16 weeks (8 weeks escalation phase, 8 weeks maintenance phase) | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed