Clinical Evaluation of lamotrigine in Epilepsy

Phase 1

Conditions: Epilepsy
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-004901-18-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Research & Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 102

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)