PPF3 compared with placebo in children and teenagers with autism
Tests PPF3 against a placebo in children and teenagers with autism.
Plain-language title generated from the registry record
Registry title: TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Key facts
- Where
- Hamilton, Kingston, London, and Toronto, CanadaSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 17 years old?
Source: NCT07893964, who can take part
Where in Canada
- McMaster UniversityHamilton, CanadaNot yet recruiting
- Queen's UniversityKingston, CanadaNot yet recruiting
- London Health Sciences CentreLondon, CanadaNot yet recruiting
- Holland Bloorview Kids Rehabilitation HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Holland Bloorview Kids Rehabilitation Hospital
- Trial code
- NCT07893964
- Record updated
- 29 October 2026
- Original description
A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of children and AdolescenTs with NeurOdeveloPmental DisorderSRead full original descriptionShow less
A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS- The TRICERATOPS Study
A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of children and AdolescenTs with NeurOdeveloPmental DisorderS
Inclusion: 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.
Exclusion: Please contact the site for details.