A Phase 2A Trial of DT402 for Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)).
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder, ASD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
Overview
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 single-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.
Interventions
- 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
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Subjective 5-question Drug Effects Questionnaire (DEQ) scores [Time frame: 1, 2, 4, 6, 8, and 24 hours post-dose]
- Pharmacokinetic Plasma concentrations [Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose]
- Pharmacokinetic Parameters (Cmax) [Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose]
- Pharmacokinetic Parameters (Tmax) [Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose]
- Pharmacokinetic Parameters (t1/2) [Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose]
- Pharmacokinetic Parameters (AUC0-inf) [Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose]
- Pharmacokinetic Parameters (AUC0-24h) [Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Spectrum Neuroscience and Treatment Institute — New York
Identifiers
NCT: NCT07303907 · MM402-105