A Phase 2A Trial of DT402 for Autism Spectrum Disorder

Part of paid clinical trials in New York, New York.

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT07303907
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • DT402 (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

Study Details

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

Key Dates

Start date
Dec 3, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 200 mg DT402
    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

Primary Outcome Measure

Change from Baseline in 11-point Numerical Rating Scale (NRS) scores [ Time Frame: Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15 ]

Central Contacts

  • Definium Therapeutics Clinical Trials Information Requests
    1-332-282-0479
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Spectrum Neuroscience and Treatment InstituteNew YorkNew York10021
Casara Ferretti
[email protected]
1-914-315-4236

Find similar trials in New York, NY

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Spectrum Neuroscience and Treatment Institute· New York, NY

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