ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
Public ClinicalTrials.gov record NCT05889273. 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
An Open-label Extension Study to Investigate 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-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.
Study identification
- NCT ID
- NCT05889273
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 46 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
- May 31, 2023
- Primary completion
- Oct 31, 2027
- Completion
- Nov 30, 2027
- Last update posted
- Jul 19, 2026
2023 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | — |
| Southwest Autism Research and Resource Center | 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 | — |
| The Children's Research Institute | 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 & Neurodevelopment | Columbia | Missouri | 65211 | — |
| Nathan Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | — |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | — |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | — |
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 3 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05889273, 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 Jul 19, 2026 · Synced Aug 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05889273 live on ClinicalTrials.gov.