ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT05081245

Run by

MapLight Therapeutics

People needed

168

Starts

2022-09-13

Expected to finish

2026-04-17

Last updated by the study team

2026-05-19

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 12 to 45 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 through 34 kg/m², inclusive
• Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
• Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
• Must be able to swallow study medication

You may not qualify if…

• Has Rett syndrome or Child Disintegrative Disorder
• Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
• History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
• History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
• Systolic blood pressure ≥140 mmHg (if adult) or >135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or >85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
• If female, is pregnant or lactating

Where it is running

• Harmonex Neuroscience Research — Dothan, Alabama, United States
• Southwest Autism Research & Resource Center, Clinical Research — Phoenix, Arizona, United States
• Cortica Healthcare — Glendale, California, United States
• NRC Research Institute — Orange, California, United States
• Cortica — San Rafael, California, United States
• Yale Child Study Center — New Haven, Connecticut, United States
• Children's National Health System - The Children's Research Institute (CRI) — Washington D.C., District of Columbia, United States
• Abba Medical Group — Miami, Florida, United States
• APG Research, LLC — Orlando, Florida, United States
• University of South Florida Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States
• Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States
• University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders — Columbia, Missouri, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Nathan Kline Institute for Psychiatric Research — Orangeburg, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Center for Autism and the Developing Brain, New York State Psychiatric Institute — White Plains, New York, United States
• Ohio State University Nisonger Center — Columbus, Ohio, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• BioBehavioral Research of Austin — Austin, Texas, United States
• Red Oak Psychiatry Associates, PA — Houston, Texas, United States
• Road Runner Research, Ltd. — San Antonio, Texas, United States
• Family Psychiatry of The Woodlands — The Woodlands, Texas, United States
• Cedar Clinical Research — Draper, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Brain and Mind Centre — Camperdown, New South Wales, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.