NCT07303907PHASE2Recruiting
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
Definium Therapeutics US, Inc.
Start Date
12/3/2025
Completion Date
8/1/2027
Summary
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Detailed Description
This study will enroll approximately twenty adults with Autism Spectrum Disorder (ASD) aged 18 to 65 years of age. This is a single-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.
Eligibility Criteria
Age Range: 18 years to 65 years
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
Interventions
DRUG
DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
Conditions
Autism Spectrum DisorderASD
Locations
Spectrum Neuroscience and Treatment Institute
New York, New York 10021
United States