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A Phase 2A Trial of DT402 for Autism Spectrum Disorder
RecruitingPhase 2
An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
Who can join
Ages 18 to 65 · All sexes
Full eligibility 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
About the study
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
What is being tested
- DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) (drug)
Sponsor: Definium Therapeutics US, Inc. · Participants: 20 · Started: Dec 3, 2025
Contact the study team
- Definium Therapeutics Clinical Trials Information Requests · Phone: 1-332-282-0479
Official record on ClinicalTrials.gov — NCT07303907
Locations in the U.S.
| New York | Spectrum Neuroscience and Treatment Institute, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.