Phase 2 Autism Spectrum Disorder Trial, Recruiting (NCT07630506)

Phase 2 Autism Spectrum Disorder Trial, Recruiting NCT07630506 Sponsor: KK Women's and Children's Hospital Condition: Autism Spectrum Disorder

Printed from Voxsanity (voxsanity.com.au) — NCT07630506 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Autism Spectrum Disorder

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

The child must be between 3 years 0 months and 10 years 11 months old at the time of joining the study
The child must weigh between 10 kg (about 22 lbs) and 30 kg (about 66 lbs) at the time of joining
The child must have an official diagnosis of Autism Spectrum Disorder (ASD) confirmed using recognised diagnostic guidelines, supported by standardised assessment tools
The child must have been on a stable routine of behavioural therapy and any medications for at least 6 months before joining
At least one parent or legal guardian must be able to read and fill out study questionnaires in English
A parent or legal guardian must provide written permission for the child to take part

Who may not be able to join:

Children who are known to be allergic or sensitive to folinic acid (a form of folate/vitamin B)
Children who are currently taking or have previously taken folinic acid or other folate supplements (regular folic acid supplements are allowed)
Children who have a vitamin B12 deficiency or a condition called pernicious anaemia (a blood disorder affecting B12 absorption)
Children who are taking certain medicines known to affect how the body processes folate, such as methotrexate, trimethoprim, fluorouracil, capecitabine, or glucarpidase (confirm with trial site if unsure about your child's medications)
Children who have a known genetic, metabolic, or chromosomal condition, or any structural differences in the brain
Children who have a history of epilepsy or seizures (other than simple febrile seizures caused by fever), or who are currently taking anti-epileptic or antipsychotic medication
Children with significant difficulties with hearing, vision, or physical movement
Children who have taken part in another clinical trial for autism in the past 6 months
Families who are unable or unwilling to attend study visits and follow study procedures

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 26 July 2026

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 6563947201

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07630506

Sponsor: KK Women's and Children's Hospital

Phase: Phase 2

Status: Recruiting

Condition: Autism Spectrum Disorder

Trial contact: 6563947201

More information: https://clinicaltrials.gov/study/NCT07630506

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

The child must be between 3 years 0 months and 10 years 11 months old at the time of joining the study
The child must weigh between 10 kg (about 22 lbs) and 30 kg (about 66 lbs) at the time of joining
The child must have an official diagnosis of Autism Spectrum Disorder (ASD) confirmed using recognised diagnostic guidelines, supported by standardised assessment tools
The child must have been on a stable routine of behavioural therapy and any medications for at least 6 months before joining
At least one parent or legal guardian must be able to read and fill out study questionnaires in English
A parent or legal guardian must provide written permission for the child to take part

Who may not be able to join:

Children who are known to be allergic or sensitive to folinic acid (a form of folate/vitamin B)
Children who are currently taking or have previously taken folinic acid or other folate supplements (regular folic acid supplements are allowed)
Children who have a vitamin B12 deficiency or a condition called pernicious anaemia (a blood disorder affecting B12 absorption)
Children who are taking certain medicines known to affect how the body processes folate, such as methotrexate, trimethoprim, fluorouracil, capecitabine, or glucarpidase (confirm with trial site if unsure about your child's medications)
Children who have a known genetic, metabolic, or chromosomal condition, or any structural differences in the brain
Children who have a history of epilepsy or seizures (other than simple febrile seizures caused by fever), or who are currently taking anti-epileptic or antipsychotic medication
Children with significant difficulties with hearing, vision, or physical movement
Children who have taken part in another clinical trial for autism in the past 6 months
Families who are unable or unwilling to attend study visits and follow study procedures

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 26 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 2

Sponsor

KK Women's and Children's Hospital

Registry

ClinicalTrials.gov

Start date

19 May 2025

Est. completion

30 June 2027

Where this trial is recruiting

🇸🇬 Singapore

Primary endpoints

Change in Pervasive Developmental Disorder-Behavior Inventory (PDDBI) Autism Composite T-Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov