An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from Baseline in 11-point Numerical Rating Scale (NRS) scores
Study Overview
Brief Summary
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Detailed Description
This study will enroll approximately twenty adults with Autism Spectrum Disorder (ASD) aged 18 to 65 years of age.
This is a multi-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) (Drug)
Outcomes
Primary Outcomes
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
The NRS is an 11-point PRO scale used to measure the severity or intensity of effects from 0 (no effect) to 10 (high severity or intensity of effect). It consists of various items related to both positive and negative effects in the autism patient population.
Secondary Outcomes
- Pharmacokinetic Parameters (AUC0-24h)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Subjective 5-question Drug Effects Questionnaire (DEQ) scores(1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (Tmax)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Plasma concentrations(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (Cmax)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (t1/2)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (AUC0-inf)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)