A Phase 2A Trial of DT402 for Autism Spectrum Disorder

Definium Therapeutics US, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder; ASD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07303907

MM402-105

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

200 mg DT402

Experimental group

Description:

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

Treatment:

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