Trial · NCT07303907
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
NCT07303907, Phase 2, Recruiting, Definium Therapeutics US, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2A Trial of DT402 for Autism Spectrum Disorder. Trials, record NCT07303907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07303907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2A Trial of DT402 for Autism Spectrum Disorder
- NCT number
- NCT07303907
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Definium Therapeutics US, Inc.
- Conditions
- Autism Spectrum Disorder, ASD
- Interventions
- DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
- First posted
- 2025-12-26
- Last updated
- 2026-09-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | Pharmacokinetic Parameters (Cmax) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Maximum concentration (Cmax). |
| Secondary | Pharmacokinetic Parameters (Tmax) | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose | Time to maximum concentration (Tmax). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07303907
GET https://conductscience.org/api/trials/v1/NCT07303907/registered