RecruitingPhase 2
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
Definium Therapeutics US, Inc. · NCT07303907
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- December 3, 2025
- Record last updated
- September 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Being studied: DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
Conditions: Autism Spectrum Disorder; ASD
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition)
- Male or Female aged 18 to 65
- Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66
Exclusion Criteria
- Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking
- First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
- Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
- Any clinically significant unstable illness
Recruiting US locations
Spectrum Neuroscience and Treatment Institute
New York, NY 10021
Site contact: Casara Ferretti · 1-914-315-4236 · cferretti@spectrumneuroscience.org
Study contacts (from the official record)
- Definium Therapeutics Clinical Trials Information Requests · 1-332-282-0479 · clinicaltrials@definiumtx.com