RecruitingPhase 2NCT07303907
A Phase 2A Trial of MM402 for Autism Spectrum Disorder
An Open-label Study Evaluating MM402 in Adults With Autism Spectrum Disorder
Sponsor
Definium Therapeutics US, Inc.
Enrollment
20 participants
Start Date
Dec 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Phase 2A Trial of MM402 Open-Label Study in Adults with Autism Spectrum Disorder
Eligibility
Min Age: 18 YearsMax Age: 45 Years
Inclusion Criteria3
- 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
Exclusion Criteria4
- 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
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Interventions
DRUGMM402 (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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07303907
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