Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
Intervention1: Memantine: Memantine will be given orally in a dose of 5 mg per day in first week, followed by 5 mg twice a day (10 mg/day) in second week and finally continue at a dose of 5 mg morning
Sponsors
Professor Jayantee Kalita
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 2 to 18 years having LGS who are using 1-5 antiseizure medication (ASM) for 4 weeks will be eligible for enrolment.
Exclusion criteria
Exclusion criteria: Hypersensitivity to memantine, alkaline urine, any degree of renal impairment, hepatic disease, or progressive cognitive or neurological deterioration. Additional exclusions will be known degenerative neurological or metabolic disorders, and concurrent use of a ketogenic diet, cannabidiol, or fenfluramine at the time of enrolment. Use of the following concomitant medications is also an exclusion criterion like amantadine, ketamine, dextromethorphan, cimetidine, ranitidine, procainamide, quinidine, quinine, hydrochlorothiazide, anticholinergics (e.g., trihexyphenidyl, benztropine, scopolamine, glycopyrrolate, atropine, oxybutynin, tolterodine), L-DOPA, and anticoagulants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in drop attacks. Equals to or more than 50% reduction in drop attack will be considered improved.Timepoint: 12 weeks after | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end points will be the percentage change from baseline in frequency of different types of seizures, 50% or greater responder rate in seizures, number of seizure free days, improvement in PedsQL Cognitive Functioning Scale and on the Clinical Global Impression- Improvement (CGI-I) scale in both the groups. Additional secondary outcomes are improvement in EEG and adverse eventsTimepoint: 12 weeks after | — |
Countries
India
Contacts
Public ContactDrJayantee Kalita
Sanjay Gandhi Post graduate Institute of Medical Sciences
Outcome results
None listed