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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  
Name  Address 
NIL   Nil 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. 
 
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.

 
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