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CTRI Number  CTRI/2025/07/091153 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of sodium valproate in children with autism in improving their clinical outcome 
Scientific Title of Study   Short term effect of sodium valproate in children with autism spectrum disorder with epileptiform discharges without clinical seizures: Double blind randomised control trial 
Trial Acronym  SEVAE trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fahima Naznin 
Designation  Senior resident doctor 
Affiliation  Christian Medical College 
Address  Department of Paediatric Neurology Room 14, 1st Floor , West Block Christian Medical College Vellore Ida Scudder Road, Vellore – 632004 Tamil Nadu, India

Vellore
TAMIL NADU
632004
India 
Phone  08011949411  
Fax    
Email  fahimanaznin00@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maya Thomas 
Designation  Professor & Guide 
Affiliation  Christian Medical College 
Address  Department of Paediatric Neurology Room 14, 1st Floor , West Block Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162285674  
Fax    
Email  paedneuro@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Maya Thomas 
Designation  Professor & Guide 
Affiliation  Christian Medical College 
Address  Department of Paediatric Neurology Room 14, 1st Floor , West Block Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162285674  
Fax    
Email  paedneuro@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Internal - fluid research grant from Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Internal - fluid research grant from Christian Medical College, Vellore 
Address  Christian Medical College Vellore Ida Scudder Road, Vellore – 632004 Tamil Nadu, India  
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 
Fahima Naznin  Christian Medical College  Department of Paediatric Neurology Room 14, Floor – , West Block Christian Medical College Vellore Ida Scudder Road, Vellore – 632004 Tamil Nadu, India
Vellore
TAMIL NADU 
08011949411

fahimanaznin00@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review board , Office of Research , Christian Medical College, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo syrup of identical color and taste as that of valproate syrup  Placebo syrup of identical color and taste as that of valproate syrup will be provided in the placebo group with children with autism with abnormal EEG without clinical seizure.  
Intervention  Sodium Valproate Syrup  Sodium Valproate Syrup will be provided in the study group with children with autism with abnormal EEG without clinical seizure. Sodium valproate will be started at 10 mg/kg/day followed by increment of 10mg/kg every week until 40mg/kg/day dose is reached at the end of 4th week. Stable dose of 40mg/kg/day will be maintained for 6 months. Baseline and follow up assessment of complete blood count, liver function test, thyroid profile will be done as part of routine management for children with autism spectrum disorder. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children from 3 to 10 years of age with Autism spectrum disorder (ASD) with epileptiform discharges without clinical seizure

Children with ASD not on pharmacological therapy for behavioral abnormalities in last 3 months
 
 
ExclusionCriteria 
Details  Children with diagnosis of syndromic ASD
Children with ASD with past history of seizure
Children with ASD on treatment with anti-seizure medication at the time of recruitment
Children with any contra indication for initiation of sodium valproate
Children with ASD on any antipsychotics, antidepressant, stimulant medication or alternate medication in last 3 months prior to enrolment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome in our study will be improvement in severity of autism as assessed by change in CARS-2 and Aberrant behavior checklist(ABC) scores at baseline and at 6 months after reaching stable dose of study drug  Primary outcome in our study will be improvement in severity of autism as assessed by change in CARS-2 and Aberrant behavior checklist(ABC) scores at baseline and at 6 months after reaching stable dose of study drug 
 
Secondary Outcome  
Outcome  TimePoints 
To assess for normalization of EEG abnormalities by the study drug, EEG will be done at baseline & again after 6 months.
To assess change in Paediatric Quality of Life (PedsQL) questionnaire score done at baseline & at 6 months.
To assess change in Children’s Sleep Habit Questionnaire (CSHQ) score done at baseline & at 6 months.  
At baseline & after 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   21/07/2025 
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="3"
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 - NO
Brief Summary  

Children visiting Paediatric Neurology clinic with a diagnosis of ASD and fulfilling inclusion , exclusion criteria will be recruited.  Informed consent will be obtained for all study participants. Participants will be randomised into two groups using randomisation software. Participants in one group will receive sodium valproate and participants in the other group will receive placeboSodium valproate syrup and placebo syrup will be dispensed in identical bottles.  Sodium valproate will be started at 10 mg/kg/day followed by increment of 10mg/kg every week until 40mg/kg/day dose is reached at the end of 4th week. Stable dose of 40mg/kg/day will be maintained for 6 months. Baseline and follow up assessment of complete blood count, liver function test, thyroid profile will be done as part of routine management for children with autism spectrum disorder and cost will be borne by patient.All children will continue to receive standard of care in the form of behavioural and speech therapy. Primary outcome – improvement in severity of autism will be assessed by CARS-2 and Aberrant Behavior checklist (ABC) scores at baseline and at 6 months after reaching stable dose of study drug.  Epileptiform discharges in EEG ,  Pediatric Quality of Life( PedsQL) and Children’s Sleep Habit Questionnaire (CSHQ) scores at baseline and at 6 months after reaching stable dose of study drug will be obtained to measure secondary outcome.  Telephonic interview will  be conducted at every weekly  after initiation of study dug and clinic visit at the end of 6 months.  Telephonic interview will be conducted by the principal investigator and will be enquired regarding any adverse event .  Patients will be asked regarding weight gain, decreased appetite , vomiting , jaundice, cold intolerance, decreased activity. If there is any adverse event at any time during study period, will be recorded and addressed.  If there are serious adverse events or adverse events of special interest related to study drug, the study drug will be discontinued.  At the end of study period and statistical analysis, the decision regarding continuation or discontinuation of anti-seizure medication will be decided and discussed with the parents.

 


 
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