A Phase 2A Trial of DT402 for Autism Spectrum Disorder

Phase 2RecruitingNCT07303907

Definium Therapeutics US, Inc.20 enrolled

Overview

A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autism Spectrum Disorder ASD

Interventions

DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Spectrum Neuroscience and Treatment Institute

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline in 11-point Numerical Rating Scale (NRS) scores

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.

Time frame: Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15

Secondary Outcomes

Subjective 5-question Drug Effects Questionnaire (DEQ) scores

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.

Time frame: 1, 2, 4, 6, 8, and 24 hours post-dose

Pharmacokinetic Plasma concentrations

Maximum Plasma Concentration \[Cmax\] of DT402 in the blood.

Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

Pharmacokinetic Parameters (Cmax)

Maximum concentration (Cmax).

Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

Pharmacokinetic Parameters (Tmax)

Time to maximum concentration (Tmax).

Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

Pharmacokinetic Parameters (t1/2)

Time to maximum concentration half-life (t1/2).

Time frame: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose

Central Contacts

Definium Therapeutics Clinical Trials Information Requests

CONTACT

1-332-282-0479 clinicaltrials@definiumtx.com

Data from ClinicalTrials.gov

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