---
title: A Phase 2A Trial of DT402 for Autism Spectrum Disorder
nct_id: NCT07303907
overall_status: RECRUITING
phase: PHASE2
sponsor: Definium Therapeutics US, Inc.
study_type: INTERVENTIONAL
primary_condition: Autism Spectrum Disorder
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07303907.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07303907"
ct_last_update_post_date: 2026-04-06
last_seen_at: "2026-05-12T07:20:01.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase 2A Trial of DT402 for Autism Spectrum Disorder

**Official Title:** An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder

**NCT ID:** [NCT07303907](https://clinicaltrials.gov/study/NCT07303907)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Definium Therapeutics US, Inc.
- **Conditions:** Autism Spectrum Disorder, ASD
- **Start Date:** 2025-12-03
- **Completion Date:** 2027-08
- **CT.gov Last Update:** 2026-04-06

## 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 single-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Arms

- **200 mg DT402** (EXPERIMENTAL) — 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

## 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

## 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

- **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)_

## Locations (1)

- Spectrum Neuroscience and Treatment Institute, New York, New York, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.spectrum neuroscience and treatment institute|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07303907.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07303907*  
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