NCT07303907 · Definium Therapeutics US, Inc.
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
What this study is about
A Phase 2A Trial of DT402 where both patients and doctors know the treatment given Study in Adults with Autism Spectrum Disorder
View original scientific description
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Interventions
DRUG
DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
A psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA
Primary outcome measures
Change from Baseline in 11-point Numerical Rating Scale (NRS) scores
Time frame: Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15
The NRS is an 11-point PRO scale used to measure the severity or intensity of effects from 0 (no effect) to 10 (high severity or intensity of effect). It consists of various items related to both positive and negative effects in the autism patient population.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2026 · Source of record for eligibility and locations