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CTRI Number  CTRI/2026/02/104655 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 22/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does adding oral Magnesium to standard treatment improve spasm control in children aged 2–24 months with Infantile Epileptic Spasm syndrome 
Scientific Title of Study   Evaluation of efficacy of add on oral Magnesium to standard therapy in children with Infantile Epileptic Spasms Syndrome aged 2-24 months: Open-labelled randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha N 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7026818199  
Fax    
Email  ndisha77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indar Kumar Sharawat 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Indar Kumar Sharawat 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Virbhadra road, Shivajinagar, Rishikesh, Uttarakhand, India - 249203 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics, All India Institute of Medical Sciences,Virbhadra road, Rishikesh, Uttarakhand, 249203 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Disha N  AIIMS Rishikesh  Pediatric Neurology Division, Department of Paediatrics, level 3, AIIMS Rishikesh, Virbhadra Road, Shivajinagar, Rishikesh, Uttarakhand, India - 249203
Dehradun
UTTARANCHAL 		 7026818199

ndisha77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G40||Epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Add-on Oral Magnesium Sulphate  Participants randomized to the intervention arm will receive oral magnesium sulphate as an add-on to standard therapy. Magnesium sulphate will be administered at a dose of 50 mg/kg/day, equivalent to 0.1 mL/kg/day of a 50% solution, given orally in two divided doses for a duration of 4 weeks. The solution will be diluted in 10–20 mL of water, milk, or juice to improve palatability and compliance. All participants in this arm will simultaneously receive standard therapy consisting of oral prednisolone (2 mg/kg/day) and oral vigabatrin (50–150 mg/kg/day) as per institutional protocol. Participants will be monitored for seizure control, adverse effects, and serum magnesium levels during follow-up visits. 
Comparator Agent  Standard Therapy Alone  Participants randomized to the comparator arm will receive standard therapy alone, without magnesium supplementation. Standard therapy includes oral prednisolone at a dose of 2 mg/kg/day along with oral vigabatrin at a dose of 50–150 mg/kg/day, initiated and titrated according to clinical response and standard institutional practice. Participants in this arm will undergo the same clinical, electroencephalographic, developmental, and safety assessments as the intervention group, but will not receive oral magnesium sulphate 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  1. Children aged between 2 and 24 months
2. Newly diagnosed cases of IESS as per ILAE 2022 diagnostic criteria
3. Parents willing to comply with the study protocol and follow up
 
 
ExclusionCriteria 
Details  1. History of hypersensitivity to magnesium sulphate
2. Known neuromuscular disorder
3. Preexisting major chronic systemic illness including cardiovascular, respiratory, gastrointestinal system or chronic renal disease
4. Caregivers not giving informed consent
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The percentage of participants achieving spasm cessation at 4 weeks in the two groups, as determined from seizure diary.  4 weeks after initiation of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
Change in spasm frequency  2, 4 and 8 weeks 
Change in Developmental Quotient (DQ) using DASII  Baseline, 4 weeks 
Change in Behavioural profile using Infant behavioural rating questionnaire   Baseline, 4 weeks 
Change in BASED score on EEG   Baseline, 4 weeks 
Change in serum magnesium levels   Baseline, 4 weeks 
Nature and frequency of adverse effects observed   4 weeks 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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   N/A 
Date of First Enrollment (India)   15/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Infantile Epileptic Spasms Syndrome is a severe developmental and epileptic encephalopathy of infancy that requires early and effective treatment to improve seizure control and neurodevelopmental outcomes. Standard first-line therapy includes hormonal treatment with oral prednisolone and vigabatrin. A substantial proportion of children have incomplete response or experience treatment-related adverse effects. Magnesium is an essential regulator of neuronal excitability and acts as a physiological N-methyl-D-aspartate  receptor antagonist. Emerging evidence suggests that magnesium supplementation may have an adjunctive role in improving seizure control and electroencephalographic outcomes in children with IESS, but data on oral magnesium therapy remain limited. This study is an open-label, parallel-group randomized controlled trial conducted at a tertiary care center. Children aged 2–24 months with newly diagnosed IESS will be randomized to receive either standard therapy alone with oral prednisolone and vigabatrin or standard therapy with add-on oral magnesium sulphate for four weeks. The primary outcome is spasm cessation at four weeks. Secondary outcomes include change in spasm frequency, EEG improvement using the BASED score, developmental and behavioural outcomes, serum magnesium levels, and adverse effects.

 
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