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CTRI Number  CTRI/2025/10/096645 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 26/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to see if adding prednisolone ( a steroid ) helps control seizures in children aged 3–12 years with a difficulty to control seizure disorder called Lennox-Gastaut syndrome 
Scientific Title of Study   Short term efficacy of adjunctive prednisolone in children with Lennox Gastaut syndrome aged 3-12 years: A parallel design, 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  Dr Prashant Jauhari 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 837,8th floor,mother and child block, AIIMS New Delhi, 110029 South West DELHI 110029 India

New Delhi
DELHI
110029
India 
Phone  9914521820  
Fax    
Email  pjauhari0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Jauhari 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 837,8th floor,mother and child block, AIIMS New Delhi, 110029 South West DELHI 110029 India

New Delhi
DELHI
110029
India 
Phone  9914521820  
Fax    
Email  pjauhari0@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Taniya Mate 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Deparment of Pediatrics, mother and child block, AIIMS New Delhi, 110029 South West DELHI 110029 India

New Delhi
DELHI
110049
India 
Phone  9145065410  
Fax    
Email  taniyamate123@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Child Neurology Division, AIIMS New Delhi 
Address  Mother Child Block AIIMS New Delhi 
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 Prashant Jauhari  AIIMS NEW DELHI  Room no 837, Child Neurology Division, Department of Pediatrics,110029 South West DELHI
South West
DELHI 		 9914521820

pjauhari0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ongoing anti-seizure medications  The ongoing antiseizure medication are optimised and kept at same dose. The number of times rescue benzodiazepine needed is noted. 
Intervention  Prednisolone  Prednisolone is started at 2 mg/kg/day for 2 weeks and tapered over next tapered over next 10 weeks. Children are monitored for any adverse effect of drug during this period. Respone is assessed at the end of 12 weeks which include. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children diagnosed with LGS as per ILAE 2017 definition with
Age 3-12 years
Have failed at least 4 ASMs with adequate dose and duration
Experiences more than four seizures per month with at least 1 seizure per week
On a stable antiseizure drug regime
On a stable ketogenic diet ratio, if diet is ongoing.

 
 
ExclusionCriteria 
Details  Primary Exclusion Criteria
1.Has a diagnosed progressive neurodegenerative or neurometabolic disorder
2.Has history of recurrent infections (one per month) requiring hospitalization in the past three months before enrollment.
3.Had a history of febrile illness within last 15 days before enrollment
4.Is a candidate for epilepsy surgery and parents willing to undergo the same.
5.Has received steroids in the past for more than two weeks as treatment for LGS
6.Is on treatment for any other (already diagnosed) chronic health condition which may worsen with steroid therapy.

Secondary exclusion criteria
To be applied after the four week observation phase
1.Occurrence of any febrile illness lasting more than 24 hours
2.Change in ASMs (use of abortive therapy with benzodiazepine is allowed)
3.Chest X-ray or Mantoux test suggestive of Tuberculosis
4.Seizure frequency less than 1 seizure per week.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapy  1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the proportion of children with LGS who develop more than 5 point improvement in T-score in any behavioral domain of Childhood behavior checklist (CBCL) between intervention arm (oral prednisolone + ASMs) and control arm (Standard ASMs alone) at 12 weeks (7 days) of therapy.
2.To compare the mean change in PINACLE score from baseline at 12 weeks (7 days) of therapy between intervention arm and control arm.
3.To compare the mean change in serum interleukin 6 levels pre and post treatment in intervention arm and control arm.
4.To compare the proportion of children with LGS who develop more than 50 percent reduction in seizures both in intervention arm (oral prednisolone along with ASMs) and control arm (Standard ASMs) at 24 weeks and 7 days (12 weeks post stopping prednisolone)
5.To evaluate the adverse effect profile of prednisolone in children with LGS
 		 24 weeks and 7 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   15/11/2025 
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="1"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pjauhari0@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Lennox Gastaut Syndrome (LGS) is a unique childhood onset epileptic encephalopathy which is often drug refractory. No consensus exists on the management of LGS in children. Non pharmacological therapies such as ketogenic diet, neuromodulation with vagal nerve stimulation and epilepsy surgery have major limitations and may not suit all. Recent studies suggest a role of neuroinflammation in the pathogenesis of LGS. Oral steroid therapy has been found to be useful in other epileptic encephalopathies associated with neuroinflammation such as Developmental and epileptic encephalopathy with spike-wave activation in sleep (D/EE-SWAS) and Infantile epileptic spasm syndrome (IESS). Small case series show that steroid therapy may be useful in reducing seizure frequency and improving neurocognitive outcome in LGS. Hence there is need for prospective studies and RCTs to analyze the efficacy of steroids on seizure frequency, EEG response and neurobehavioral outcome in LGS 
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