At a glance
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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 -
In Brief
A Phase 4 clinical trial evaluating Lamotrigine tablets 25/100 mg for Epilepsy. Completed, enrolled 33 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.