PPF3 vs placebo in children and teens with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 randomized, placebo-controlled trial examining the effect of PPF3 in individuals aged 8 to 17 with autism spectrum disorder who weigh at least 30 kg and have previously participated in the POND cohort. Participants are outpatients and must meet DSM-5 criteria for ASD, with confirmation by ADOS-2, and have a CGI-S score of at least 4. Stable concomitant medications are allowed if unchanged for the prior month (six weeks for fluoxetine). The study is conducted across multiple Ontario sites, with Holland Bloorview Kids Rehabilitation Hospital as lead sponsor and support from the Ontario Brain Institute and Purposeful.

Why it matters

Who can join: the full rules

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:

Please contact the site for details

Where it's running

• Holland Bloorview Kids Rehabilitation Hospital
  Toronto, Ontario, Canada Recruiting
• McMaster University
  Hamilton, Ontario, Canada Not yet recruiting
• Queen's University
  Kingston, Ontario, Canada Not yet recruiting
• London Health Sciences Centre
  London, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Evdokia Anagnostou, MD — Holland Bloorview Kids Rehabilitation Hospital
• Study coordinator: Ches Souru, MD
• Email: csouru@hollandbloorview.ca
• Phone: 416-425-6220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.