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Effect of sodium valproate in children with autism in improving their clinical outcome

Short term effect of sodium valproate in children with autism spectrum disorder with epileptiform discharges without clinical seizures: Double blind randomised control trial - SEVAE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091153
Enrollment
80
Registered
2025-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: 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

Sponsors

Internal - fluid research grant from Christian Medical College, Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 drugTimepoint: 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

MeasureTime frame
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.Timepoint: At baseline & after 6 months—

Countries

India

Contacts

Public ContactDr Maya Thomas

Christian Medical College

paedneuro@cmcvellore.ac.in04162285674

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026