Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-12-03
2027-08-31
Brief Summary
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Detailed Description
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This is a single-center, open-label study to evaluate the effects after a single administration of MM402 to adults with ASD.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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200 mg MM402 (R-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
MM402 (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
Interventions
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MM402 (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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
ALL
No
Sponsors
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Mind Medicine, Inc.
INDUSTRY
Responsible Party
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Locations
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Spectrum Neuroscience and Treatment Institute
New York, New York, United States
Countries
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Central Contacts
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Mind Medicine, Inc. Clinical Trials Information Requests
Role: CONTACT
Phone: 1-332-282-0479
Email: [email protected]
Facility Contacts
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Casara Ferretti
Role: primary
Other Identifiers
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MM402-105
Identifier Type: -
Identifier Source: org_study_id