Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
NCT05081245 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG ML-004 (IR)/(ER) tablet
- DRUG ML-004 Placebo
Study Locations (20)
California
- Cortica Healthcare — Glendale
- NRC Research Institute — Orange
- Cortica — San Rafael
Florida
- Abba Medical Group — Miami
- APG Research, LLC — Orlando
- University of South Florida Psychiatry and Behavioral Neurosciences — Tampa
New York
- Nathan Kline Institute for Psychiatric Research — Orangeburg
- Richmond Behavioral Associates — Staten Island
- Center for Autism and the Developing Brain, New York State Psychiatric Institute — White Plains
Texas
- BioBehavioral Research of Austin — Austin
- Red Oak Psychiatry Associates, PA — Houston
Alabama
- Harmonex Neuroscience Research — Dothan
Arizona
- Southwest Autism Research & Resource Center, Clinical Research — Phoenix
Connecticut
- Yale Child Study Center — New Haven
District of Columbia
- Children's National Health System - The Children's Research Institute (CRI) — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05081245
The ClinicalTrials.gov registry entry for NCT05081245 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MapLight Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions — of which ML-004 (IR)/(ER) tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05081245 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05081245 about?
NCT05081245 is a clinical study titled "ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)". 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 def...
What is the current status of trial NCT05081245?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2022-09-13. Estimated completion is 2026-11.
What conditions does trial NCT05081245 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05081245?
The interventions under investigation include: ML-004 (IR)/(ER) tablet (DRUG), ML-004 Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05081245?
This trial is sponsored by MapLight Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05081245 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.