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

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• 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.
  • 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.