Recruiting
Phase 2

MM402

Sponsor:

Definium Therapeutics US, Inc.

Code:

NCT07303907

Conditions

Autism Spectrum Disorder

ASD

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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

Conditions

Autism Spectrum Disorder

ASD

Study ID

NCT07303907

Start date

Dec 3, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 200 mg DT402

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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Definium Therapeutics Clinical Trials Information Requests

1-332-282-0479clinicaltrials@definiumtx.com

Locations

Spectrum Neuroscience and Treatment Institute

Recruiting

New York, New York, United States, 10021

Contacts

Casara Ferretti

1-914-315-4236cferretti@spectrumneuroscience.org

More Information

Sponsor

Definium Therapeutics US, Inc.

Last update posted

Sep 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Definium Therapeutics US, Inc. on 2026-09-02.