A Phase 2A Trial of MM402 for Autism Spectrum Disorder

NCT07303907 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MM402-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2A Trial of MM402 Open-Label Study in Adults with Autism Spectrum Disorder

Conditions

ASD; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15

Secondary Outcomes (7)

• Subjective 5-question Drug Effects Questionnaire (DEQ) scores

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

• Pharmacokinetic Plasma concentrations

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

• Pharmacokinetic Parameters (Cmax)

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

• Pharmacokinetic Parameters (Tmax)

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

• Pharmacokinetic Parameters (t1/2)

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

Study Arms (1)

200 mg MM402 (R-MDMA)

EXPERIMENTAL

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

Drug: MM402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))

Interventions

MM402 (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

Also known as: MDMA

200 mg MM402 (R-MDMA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 45
• Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66

You may not qualify if:

• 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

Sponsors & Collaborators

• Definium Therapeutics US, Inc.: lead

Study Sites (1)

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Central Study Contacts

Definium Therapeutics Clinical Trials Information Requests

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 26, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2025-12

Locations

US (1)