An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
Definium Therapeutics US, Inc.
Summary
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- 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…
Interventions
- DrugDT402 (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
Location
- Spectrum Neuroscience and Treatment InstituteNew York, New York