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RecruitingNCT07893964TRICERATOPSUpdated Oct 26, 2026

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

A Phase 2 interventional study of PPF3 and Placebo in Autism Disorder, sponsored by Holland Bloorview Kids Rehabilitation Hospital. Recruiting at 3 sites in Canada. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Holland Bloorview Kids Rehabilitation Hospital · Phase 2, Interventional, and Other

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
8 Years to 17 Years
Sex
All
01

Study summary

A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of children and AdolescenTs with NeurOdeveloPmental DisorderS

02

Conditions studied

  • Autism Disorder

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03

In context

Autistic Disorder

1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital is the lead sponsor of 64 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Please contact the site for details

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Arm 1

    PPF3

    Drug: PPF3

  • Placebo comparator
    Arm 2

    Placebo

    Drug: Placebo

Interventions

  • DrugPPF3

    Investigational

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Adverse event

    Time frame: From enrollment to the end of week 16

  2. Clinical Global Impression Scale

    Time frame: From Screening to Week 16

07

Study locations

1 of 3 sites recruiting
  • McMaster University
    Hamilton, Ontario L8L 0A4, Canada
    • Shamama Raza · Contact · razas19@mcmaster.ca · razas19@mcmaster.ca
    • Elisabetta Trinari, MD · Principal investigator
    Not yet recruiting
  • Queen's University
    Kingston, Ontario K7L 3N6, Canada
    • Stamatoula Pasvanis · Contact · s.pasvanis@queensu.ca · 613-533-6000
    • Marc Woodbury-Smith, MD · Principal investigator
    Not yet recruiting
  • Holland Bloorview Kids Rehabilitation Hospital
    Toronto, Ontario M4G 1R8, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 49 non-industry phase 2 interventional studies under Autistic Disorder, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 24 months is below that.

Counting every sponsor, half of 60 studies reached it within 39 months; a quarter within 24 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 26, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2028
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893964
Lead sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Ontario Brain Institute (Funder), Purposeful
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Ches Souru, MD
Contact
csouru@hollandbloorview.ca
416-425-6220 ext. 3297
Evdokia Anagnostou, MD
Contact
eanagnostou@hollandbloorview.ca
416-753-6005
Evdokia Anagnostou, MD
principal investigator · Holland Bloorview Kids Rehabilitation Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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