NCT05889273Active, not recruitingPhase 2
ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 May 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- MapLight Therapeutics
- Diseases
- Autism
- NCT number
- NCT05889273
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 1 Jun 2023 to the primary completion date, 30 Nov 2027
- 21 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has Rett syndrome or Child Disintegrative Disorder
- History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
- Has a clinical history of uncontrolled or severe hypertension
Other
- Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
- If female, is pregnant or lactating
Who the study is looking for
- Has completed Study ML-004-002 within the past 90 days
- Age 12 years to 46 years at screening
- Has a designated care/study partner who can reliably report on symptoms
- Has a diagnosis of Autism Spectrum Disorder (ASD)
- Has a body mass index (BMI) ≥18 kg/m²
- Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening
- Must be able to swallow study medication
Age in the registry: 12 years to 46 years · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brain and Mind Centre Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| The Royal Children's Hospital, Murdoch Children's Research Institute Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Holland Bloorview Kids Rehabilitation Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BioBehavioral Research of Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| NeuroBehavioral Medicine Group Coordinator of this site? Confirm its status | Bloomfield Hills | United States | Unknown status |
| University of Missouri, Thompson Center for Autism & Neurodevelopment Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Harmonex Neuroscience Research Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| Cortica Healthcare Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Suburban Research Associates Coordinator of this site? Confirm its status | Media | United States | Unknown status |
| Abba Medical Group Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Yale Child Study Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| NRC Research Institute Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Nathan Kline Institute for Psychiatric Research Coordinator of this site? Confirm its status | Orangeburg | United States | Unknown status |
| APG Research, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Southwest Autism Research and Resource Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Road Runner Research, Ltd Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Cortica Coordinator of this site? Confirm its status | San Rafael | United States | Unknown status |
| Richmond Behavioral Associates Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| University of South Florida, Psychiatry and Behavioral Neurosciences Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Family Psychiatry of The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| The Children's Research Institute Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.