| 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
|
|
|
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
|
|
|
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 placebo. Sodium 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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