Loading clinical trials...
Loading clinical trials...
An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
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.
Age
12 - 46 years
Sex
ALL
Healthy Volunteers
No
Harmonex Neuroscience Research
Dothan, Alabama, United States
Southwest Autism Research and Resource Center
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
The Children's Research Institute
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
Start Date
June 1, 2023
Primary Completion Date
November 1, 2027
Completion Date
December 1, 2027
Last Updated
March 16, 2026
120
ESTIMATED participants
ML-004 (IR)/(ER) tablet
DRUG
Lead Sponsor
MapLight Therapeutics
NCT06290258
NCT05750095
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05874466