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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 single-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Definium Therapeutics Clinical Trials Information Requests | Contact | 1-332-282-0479 | clinicaltrials@definiumtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Neuroscience and Treatment Institute | Recruiting | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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|
| 1, 2, 4, 6, 8, and 24 hours post-dose |
| Pharmacokinetic Plasma concentrations | Maximum Plasma Concentration [Cmax] of DT402 in the blood. | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose |
| Pharmacokinetic Parameters (Cmax) | Maximum concentration (Cmax). | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose |
| Pharmacokinetic Parameters (Tmax) | Time to maximum concentration (Tmax). | 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). | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose |
| Pharmacokinetic Parameters (AUC0-inf) | Area under the concentration curve from time 0 to infinity (AUC0-inf). | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose |
| Pharmacokinetic Parameters (AUC0-24h) | Area under the concentration curve from time 0 to 24 hour (AUC0-24h). | pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose |
| Organic Chemicals |