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

NCT02100644 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-11-17

Study results available
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Summary

The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy patients aged 15 years or older, whose seizures are well controlled by VPA monotherapy.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-12
Primary Completion
2015-05-11
Completion
2015-05-11

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100644 on ClinicalTrials.gov