Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study

PHASE4CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

April 12, 2014

Primary Completion Date

May 11, 2015

Study Completion Date

May 11, 2015

Conditions
Epilepsy
Interventions
DRUG

Lamotrigine tablets 25/100 mg

Lamotrigine (LTG) is administered according to the package insert: that is, 25 mg of LTG will be orally administered once every other day for the first 2 weeks and then once daily for the next 2 weeks. Thereafter, the dose will be gradually escalated by 25-50 mg every 1-2 week for once or twice daily administration. During the VPA reduction phase and LTG\&VPA maintenance phase, as specified in the information of package insert, maintenance dose of LTG will be administered twice daily.

Trial Locations (7)

664-8540

GSK Investigational Site, Hyōgo

892-0844

GSK Investigational Site, Kagoshima

606-8507

GSK Investigational Site, Kyoto

560-8565

GSK Investigational Site, Osaka

351-8551

GSK Investigational Site, Saitama

430-8558

GSK Investigational Site, Shizuoka

185-0012

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02100644 - Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study | Biotech Hunter | Biotech Hunter