ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
Launched by MAPLIGHT THERAPEUTICS · Jun 1, 2023
Trial Information
Current as of July 04, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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 positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
- • Has a clinical history of uncontrolled or severe hypertension
- • If female, is pregnant or lactating
About Maplight Therapeutics
Maplight Therapeutics is a pioneering biotechnology company dedicated to advancing the field of precision medicine through the development of innovative therapies targeting complex diseases. Leveraging cutting-edge technologies and a deep understanding of disease biology, Maplight aims to identify and validate novel therapeutic targets, ultimately translating scientific discoveries into effective treatments. The company is committed to improving patient outcomes by personalizing treatment approaches and ensuring that each therapeutic candidate is rigorously evaluated in clinical trials, reflecting their dedication to scientific excellence and patient-centric care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Media, Pennsylvania, United States
Phoenix, Arizona, United States
Houston, Texas, United States
Orangeburg, New York, United States
Bloomfield Hills, Michigan, United States
Columbus, Ohio, United States
Dothan, Alabama, United States
Toronto, Ontario, Canada
San Antonio, Texas, United States
Orange, California, United States
Orlando, Florida, United States
Camperdown, New South Wales, Australia
Staten Island, New York, United States
Draper, Utah, United States
Tampa, Florida, United States
Parkville, Victoria, Australia
Columbia, Missouri, United States
Glendale, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported