PPF3TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS

Inclusion Criteria:

• Outpatients 8-17 years of age, inclusive, with a weight ≥ 30 kg.
• Already have participated in POND cohort
• Females of childbearing potential who are sexually active and agree to use medically acceptable birth control throughout the study and at least one week post last dose of study drug.
• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (American Psychiatric Association, 2013) for ASD. Diagnosis will be supported by the ADOS-2. Diagnostic and Statistical Manual (DSM-5) criteria will be established by a clinician with expertise with individuals with ASD.
• Have a Clinical Global Impression-Severity (CGI-S; Guy, 1976)) score ≥ 4 (moderately ill)
• If already receiving interventions, must meet the following criteria:
• If receiving concomitant medications affecting behaviour, must be on a stable dose during the month prior to screening (6 weeks for Fluoxetine) and will not electively modify ongoing medications for the study duration.

b. If already receiving stable non-pharmacological behavioural interventions, have stable participation during 3 months prior to screening, and will not electively modify ongoing interventions.

• Have a negative pregnancy test at screening for patients who have experienced menarche
• Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Qualified Investigator.

Ability to obtain written informed consent from the participant, if developmentally appropriate. If a participant does not have the capacity to consent, ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian.

Exclusion Criteria:

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