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NCT Number: NCT07303907

A Phase 2A Trial of DT402 for Autism Spectrum Disorder

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

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Key information

Conditions

Autism Spectrum Disorder ASD Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spectrum Neuroscience and Treatment Institute

New York, 10021, United States

Location status: Recruiting

Location contact

Casara Ferretti

CONTACT

[email protected]

1-914-315-4236

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: MM402, R-MDMA, MDMA

Primary outcomes

  1. 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.

Secondary outcomes

  1. Subjective 5-question Drug Effects Questionnaire (DEQ) scores

    Time frame: 1, 2, 4, 6, 8, and 24 hours post-dose

    The Drug Effects Questionnaire is used in studies to assess the participant's acute subjective effects after ingesting substances. It consists of 5 PRO items. The analog scale of responses ranges from "not at all" to "extremely." The score is determined by the distance between the left anchor point and the participant's mark on the line. Each item is scored separately.

  2. Pharmacokinetic Plasma concentrations

    Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

    Maximum Plasma Concentration [Cmax] of DT402 in the blood.

  3. Pharmacokinetic Parameters (Cmax)

    Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

    Maximum concentration (Cmax).

  4. Pharmacokinetic Parameters (Tmax)

    Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

    Time to maximum concentration (Tmax).

  5. Pharmacokinetic Parameters (t1/2)

    Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

    Time to maximum concentration half-life (t1/2).

  6. Pharmacokinetic Parameters (AUC0-inf)

    Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

    Area under the concentration curve from time 0 to infinity (AUC0-inf).

  7. Pharmacokinetic Parameters (AUC0-24h)

    Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

    Area under the concentration curve from time 0 to 24 hour (AUC0-24h).

Study contacts

Contact information is provided by the study sponsor or research team.

Definium Therapeutics Clinical Trials Information Requests

CONTACT

[email protected]

1-332-282-0479

Sponsors and collaborators

Lead sponsor

Definium Therapeutics US, Inc.

Industry

Registry information

Official study title

An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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