Single-dose DT402 treatment for adults with autism
Official title: An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
Run by Definium Therapeutics US, Inc. · NCT07303907 · Data updated 2026-11-12
This open-label test will see if a single dose of DT402 improves social communication in adults with autism.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Definium Therapeutics US, Inc. Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | December 3, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07303907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with a confirmed ASD diagnosis and clinically significant social deficits (SRS-2 ≥66) who do not have current substance use disorder, a first-degree relative with psychosis or bipolar disorder, significant eye problems, or unstable medical conditions are the intended participants.
✕Probably not a fit
People with psychotic or bipolar disorder in first-degree relatives, current alcohol or substance use disorder, significant eye issues, unstable illnesses, or those outside the 18–65 age range are unlikely to qualify or receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, open-label Phase 2A study will enroll about 20 adults aged 18–65 with diagnosed autism spectrum disorder who meet a threshold of social impairment on the SRS-2. Participants will receive a single administration of DT402 (the R‑enantiomer of MDMA) and will be followed for safety and changes in social and communication measures. Key exclusions include first-degree relatives with psychosis or bipolar disorder, current substance use disorder (excluding nicotine and caffeine), significant eye abnormalities that interfere with eye tracking, and any unstable medical illness. The study is intended to collect preliminary safety data and early signals of effect to guide larger controlled trials.
Why it matters
Potential benefit: If successful, DT402 could improve social communication and related functioning for some adults with ASD.
How similar studies have gone: MDMA-assisted approaches have shown promising results in PTSD, but using DT402 (the R‑enantiomer of MDMA) in adults with ASD is largely novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition) 2. Male or Female aged 18 to 65 3. Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66 Exclusion Criteria: 1. Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) 4. Any clinically significant unstable illness
Where it's running
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Spectrum Neuroscience and Treatment Institute
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Definium Therapeutics Clinical Trials Information Requests
- Email: clinicaltrials@definiumtx.com
- Phone: 1-332-282-0479
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.