A Phase 2A Trial of DT402 for Autism Spectrum Disorder

Purpose

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

Conditions

  • Autism Spectrum Disorder
  • ASD

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 65 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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: DT402 (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 names:
    • MM402
    • R-MDMA
    • MDMA

Recruiting Locations

Spectrum Neuroscience and Treatment Institute
New York, New York 10021
Contact:
Casara Ferretti
1-914-315-4236
cferretti@spectrumneuroscience.org

More Details

Status
Recruiting
Sponsor
Definium Therapeutics US, Inc.

Study Contact

Definium Therapeutics Clinical Trials Information Requests
1-332-282-0479
clinicaltrials@definiumtx.com

Detailed Description

This study will enroll approximately twenty adults with Autism Spectrum Disorder (ASD) aged 18 to 65 years of age. This is a single-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.