ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
Public ClinicalTrials.gov record NCT05081245. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.
Study identification
- NCT ID
- NCT05081245
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2022 (Actual)
- Primary completion
- Mar 10, 2026 (Actual)
- Completion
- Apr 17, 2026 (Actual)
- Last update posted
- May 19, 2026
2022 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | — |
| Southwest Autism Research & Resource Center, Clinical Research | Phoenix | Arizona | 85006 | — |
| Cortica Healthcare | Glendale | California | 91203 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Cortica | San Rafael | California | 94903 | — |
| Yale Child Study Center | New Haven | Connecticut | 06519 | — |
| Children's National Health System - The Children's Research Institute (CRI) | Washington D.C. | District of Columbia | 20010 | — |
| Abba Medical Group | Miami | Florida | 33176 | — |
| APG Research, LLC | Orlando | Florida | 32803 | — |
| University of South Florida Psychiatry and Behavioral Neurosciences | Tampa | Florida | 33613 | — |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | — |
| University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders | Columbia | Missouri | 65211 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Nathan Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Center for Autism and the Developing Brain, New York State Psychiatric Institute | White Plains | New York | 10605 | — |
| Ohio State University Nisonger Center | Columbus | Ohio | 43210 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | — |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23220 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05081245, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05081245 live on ClinicalTrials.gov.