Autism DisorderPhase 2TRICERATOPSNCT07893964
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
A Phase 2 study testing PPF3 in people with Autism Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 4 sites in Canada.
Trial summary
A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of children and AdolescenTs with NeurOdeveloPmental DisorderS Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Autism Disorder
- What is being tested?
- PPF3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2026to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- 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.
Who cannot join
- Please contact the site for details
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
McMaster University
Hamilton, Ontario, L8L 0A4
Shamama Raza, razas19@mcmaster.ca ext. 3297, razas19@mcmaster.ca
Elisabetta Trinari, MD
- Not yet recruiting
Queen's University
Kingston, Ontario, K7L 3N6
Stamatoula Pasvanis, 613-533-6000 ext. 76923, s.pasvanis@queensu.ca
Marc Woodbury-Smith, MD
- Not yet recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Kayleigh Tam, 519.685.8500 ext. 53333, Kayleigh.Tam@lhsc.on.ca
Janys Lim, MD
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
Ches Souru, MD, 416-425-6220 ext. 3297, csouru@hollandbloorview.ca
Evdokia Anagnostou, MD, 416-753-6005, eanagnostou@hollandbloorview.ca
About this study
Official title: 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
- Conditions
- Autism Disorder
- Being tested
- PPF3, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPF3Drug
Investigational
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | PPF3 Receives: Drug: PPF3 |
| Arm 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Measured: From enrollment to the end of week 16
Clinical Global Impression Scale
Measured: From Screening to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute (Funder), Purposeful
- Responsible party
- Sponsor
- Investigators
- Evdokia Anagnostou, MD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893964
- Sponsor's protocol ID
- PPF3-10-2025
- Acronym
- TRICERATOPS
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS- The TRICERATOPS Study
- ClinicalTrials.gov ID
- NCT07893964
- Acronym / sponsor ID
- TRICERATOPS / PPF3-10-2025
- Conditions
- Autism Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Ontario Brain Institute (Funder), Purposeful
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized Placebo-Controlled TRIal of PPF3 vs. PlaCEbo in the TReatment of children and AdolescenTs with NeurOdeveloPmental DisorderS
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PPF3PPF3 |
| Arm 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (1 listed)
- Please contact the site for details
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPF3Investigational | Drug | Arm 1 |
| PlaceboPlacebo | Drug | Arm 2 |
Primary outcome
Adverse event
Time frame: From enrollment to the end of week 16
Clinical Global Impression Scale
Time frame: From Screening to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evdokia Anagnostou, MD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPF3 in people with Autism Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ches Souru, MD (416-425-6220 ext. 3297, csouru@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: From enrollment to the end of week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.