RecruitingPhase 2MDMA

A Phase 2A Trial of MM402 for Autism Spectrum Disorder

Sponsored by Definium Therapeutics US, Inc.

NCT ID
NCT07303907
Target Enrollment
20 participants
Start Date
2025-12-03
Est. Completion
2027-08

About This Study

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

Conditions Studied

Autism Spectrum DisorderASD

Interventions

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

Eligibility

Age:18 Years - 45 Years
Healthy Volunteers:No
View full eligibility criteria
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 45
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 Locations (1)

Spectrum Neuroscience and Treatment Institute
New York, New York, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Definium Therapeutics Clinical Trials Information Requests
CONTACT
1-332-282-0479clinicaltrials@definiumtx.com
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

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