ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
Autism Spectrum Disorder
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Autism, Autism Spectrum Disorder, social communication deficit
Eligibility Criteria
Inclusion Criteria:
- 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)
- Full scale IQ (or equivalent) ≥70 score
- Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
- Must be able to swallow study medication
Exclusion Criteria:
- 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 ≥160 mmHg, or diastolic blood pressure ≥100, or a clinical history of uncontrolled or severe hypertension
- If female, is pregnant or lactating
Sites / Locations
- Harmonex Neuroscience ResearchRecruiting
- Southwest Autism Research & Resource Center, Clinical ResearchRecruiting
- University of California, San FranciscoRecruiting
- Yale Child Study CenterRecruiting
- Children's National Health System - The Children's Research Institute (CRI)Recruiting
- APG Research, LLCRecruiting
- University of South Florida Psychiatry and Behavioral NeurosciencesRecruiting
- AMR-Baber Research IncRecruiting
- Massachusetts General Hospital's Lurie Center for AutismRecruiting
- Neurobehavioral Medicine GroupRecruiting
- University of Missouri, Thompson Center for Autism & Neurodevelopmental DisordersRecruiting
- Hassman Research InstituteRecruiting
- Jersey Shore University Medical CenterRecruiting
- Nathan Kline Institute for Psychiatric ResearchRecruiting
- Richmond Behavioral AssociatesRecruiting
- Center for Autism and the Developing Brain, New York State Psychiatric InstituteRecruiting
- Ohio State University Nisonger CenterRecruiting
- Suburban Research AssociatesRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Red Oak Psychiatry Associates, PARecruiting
- Road Runner Research, Ltd.Recruiting
- Cedar Clinical ResearchRecruiting
- Seattle Children's HospitalRecruiting
- Brain and Mind CentreRecruiting
- Children's Health Queensland Hospital and Health ServiceRecruiting
- Mater ResearchRecruiting
- Flinders Medical CentreRecruiting
- The Royal Children's Hospital, Murdoch Children's Research InstituteRecruiting
- OCT Research ULC (dba Okanagan Clinical Trials)Recruiting
- Lawson Health Research Institute/ London Health Sciences CentreRecruiting
- Holland Bloorview Kids Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ML-004 (IR)/(ER) tablet
ML-004 Placebo
ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets).
Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets).