ASD, Autism Spectrum Disorder
Conditions
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.
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
Sponsors
Definium Therapeutics US, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 11-point Numerical Rating Scale (NRS) scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective 5-question Drug Effects Questionnaire (DEQ) scores | 1, 2, 4, 6, 8, and 24 hours post-dose | The Drug Effects Questionnaire is used in studies to assess the participant's acute subjective effects after ingesting substances. It consists of 5 PRO items. The analog scale of responses ranges from "not at all" to "extremely." The score is determined by the distance between the left anchor point and the participant's mark on the line. Each item is scored separately. |
| Pharmacokinetic Plasma concentrations | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Maximum Plasma Concentration \[Cmax\] of DT402 in the blood. |
| Pharmacokinetic Parameters (Cmax) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Maximum concentration (Cmax). |
| Pharmacokinetic Parameters (Tmax) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Time to maximum concentration (Tmax). |
| Pharmacokinetic Parameters (t1/2) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Time to maximum concentration half-life (t1/2). |
| Pharmacokinetic Parameters (AUC0-inf) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Area under the concentration curve from time 0 to infinity (AUC0-inf). |
| Pharmacokinetic Parameters (AUC0-24h) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Area under the concentration curve from time 0 to 24 hour (AUC0-24h). |
Countries
United States
Contacts
CONTACTDefinium Therapeutics Clinical Trials Information Requests
Outcome results
None listed