A Phase 2A Trial of DT402 for Autism Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDefinium Therapeutics US, Inc.
About this trial
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Eligibility criteria
Qualifiers
Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition)
Male or Female aged 18 to 65
Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66
Disqualifiers
Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking
First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
Any clinically significant unstable illness
Trial design
Treatments tested in this trial
- DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov