| CTRI Number |
CTRI/2026/01/100753 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of adding Memantine to treatment in Lennox Gastaut Syndrome. |
|
Scientific Title of Study
|
Safety and efficacy of memantine add on in Lennox-Gastaut Syndrome: A randomized double blind placebo- controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJayantee Kalita |
| Designation |
Professor and Head |
| Affiliation |
sanjay gandhi post graduate institute of medical sciences |
| Address |
Department of neurology,sanjay gandhi post graduate institute of medical sciences
Lucknow UTTAR PRADESH 226014 India |
| Phone |
09450411673 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Akhilendra Kumar |
| Designation |
Senior Resident |
| Affiliation |
Sanjay Gandhi Post graduate Institute of Medical Sciences |
| Address |
Department of Neurology,sanjay gandhi post graduate institute of medical sciences
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8707413053 |
| Fax |
|
| Email |
akhilendrakumar02@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrJayantee Kalita |
| Designation |
Professor and Head |
| Affiliation |
sanjay gandhi post graduate institute of medical sciences |
| Address |
Department of neurology,sanjay gandhi post graduate institute of medical sciences
Lucknow UTTAR PRADESH 226014 India |
| Phone |
09450411673 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of neurology, sanjay gandhi post graduate institute of medical sciences, raebareli road, lucknow, uttar pradesh, india-226014 |
|
|
Primary Sponsor
|
| Name |
Professor Jayantee Kalita |
| Address |
Department of neurology,sanjay gandhi post graduate institute of medical sciences |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Professor Jayantee Kalita |
sanjay gandhi post graduate institute of medical sciences |
Department of neurology, sanjay gandhi post graduate institute of medical sciences, Raebareli Road Lucknow, Uttar Pradesh,India-226014 Lucknow UTTAR PRADESH |
09450411673
jayanteek@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 and 10 mg evening (15 mg/day) from third week onwards. There after dose will be maintained till 12 weeks. After the study period, all the patients will receive memantine depending on their consent. |
| Comparator Agent |
saccharine tablet |
The placebo arm will receive saccharine tablet in the similar schedule. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2 to 18 years having LGS who are using 1-5 antiseizure medication (ASM) for 4 weeks will be eligible for enrolment. |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change from baseline in drop attacks. Equals to or more than 50% reduction in drop attack will be considered improved. |
12 weeks after |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 events |
12 weeks after |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic encephalopathy characterized by classical triad of 1). Multiple types of seizure, 2). Cognitive impairment and 3). Diffuse slow spike and slow wave discharges on EEG. In this study, we propose to evaluate the Safety and efficacy of memantine add on compared to placebo in Lennox-Gastaut Syndrome. We will also evaluate the effect of memantine on the cognitive function in patient with LGS by the use of six item Pediatric Quality of Life Inventory (PedsQL) Cognitive Functioning Scale, effect on the EEG changes and effect on the Clinical Global Impression Improvement Scale (CGI-I) compared to those who will receive placebo. Children aged 2 to 18 years having LG syndrome who are using 1-5 ASM for 1 month will be included. After the eligibility checking, patients will be in 1 month screening period during which caregiver will be advised to maintain a diary recording of daily seizure frequency, type of seizure and drop attacks. The demographic details including age, gender duration of illness and developmental milestones will be enquired. Height, weight and BMI will be noted. Any history of antenatal, perinatal and postnatal events will be recorded. Their baseline blood counts, hemoglobin, serum chemistry including liver function test, kidney function test, sodium, potassium, calcium alkaline phosphatase and thyroid stimulating hormone, vitamin B12 and folic acid will be done. Genetic study will be considered in affording patients. Cranial MRI scan findings will be noted. After a 4-week of baseline screening period for recoding of seizure frequency, patients will be randomized to memantine or placebo using simple 1:1 randomization after obtaining inform consent. The sample size is calculated and 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 and 10 mg evening (15 mg/day) from third week onwards. There after dose will be maintained till 12 weeks. The placebo arm will receive similar dose of saccharine. In addition to adverse event recording throughout the study, the routine safety assessments include a physical and a neurological evaluation will be performed at each study visit. Study visits will be scheduled monthly till 3 months, or any time if any medical emergency situation arise. Clinical laboratory tests (biochemistry, hematology, urine analysis) will be conducted at the time of entry into the study, at the end the study or in the situation with adverse event. EEG will be performed at baseline and at the end of the study. Brain magnetic resonance imaging (MRI) evaluations will also baseline. The primary end point will the percentage change from baseline in drop attacks in memantine group compared to the placebo group. The secondary end points will be the percentage change from baseline in frequency of different types of seizures (generalized convulsive seizures, secondary generalized convulsive seizure, focal to bilateral tonic-clonic, tonic, atonic, or tonic or atonic). A 50% or greater reduction in seizure, 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 events. The primary and secondary outcome parameter will be analyzed using parametric or nonparametric tests depending on the data. Intension to treat and per protocol analysis of the primary outcome will be done. |