A Phase 2A Trial of DT402 for Autism Spectrum Disorder

NCT07303907 · tracked via the Priya Life Science USA tracker

Sponsor

Definium Therapeutics US, Inc.

Phase

Phase 2

Started

2025-12-03

Last updated

2026-09-02

Condition(s) studied

Autism Spectrum DisorderASD

Investigational drug(s) / intervention(s)

DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))

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

Study summary

A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Change from Baseline in 11-point Numerical Rating Scale (NRS) scores — 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.

Trial sites (1)

Facility	City	Region	Status
Spectrum Neuroscience and Treatment Institute	New York	New York	Recruiting

More Definium Therapeutics US, Inc. trials in the USA

A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage) Active, not recruiting

A Phase 3 Trial of DT120 for Major Depressive Disorder (Emerge) Active, not recruiting

A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) Recruiting

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama) Active, not recruiting

Other trials for the same condition

Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder (ASD) Starting soon

International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder Recruiting

Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism Recruiting

Mental Health, Intellectual and Neurodevelopmental Disorder Detection With Artificial Intelligence Models Enrolling by invitation

Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined. Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303907 on ClinicalTrials.gov ↗ ← All trials in the USA