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A Phase 2A Trial of DT402 for Autism Spectrum Disorder

NCT07303907 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-06

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • Definium Therapeutics US, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303907 on ClinicalTrials.gov