Autism Spectrum Disorder Clinical Trial
Official title:
An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Verified date | May 2024 |
Source | MapLight Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 120 |
Est. completion date | June 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 46 Years |
Eligibility | 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Brain and Mind Centre | Camperdown | New South Wales |
Australia | The Royal Children's Hospital, Murdoch Children's Research Institute | Parkville | Victoria |
Canada | Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario |
United States | University of Missouri, Thompson Center for Autism & Neurodevelopment | Columbia | Missouri |
United States | Harmonex Neuroscience Research | Dothan | Alabama |
United States | Cedar Clinical Research | Draper | Utah |
United States | Red Oak Psychiatry Associates, PA | Houston | Texas |
United States | Suburban Research Associates | Media | Pennsylvania |
United States | APG Research, LLC | Orlando | Florida |
United States | Southwest Autism Research and Resource Center | Phoenix | Arizona |
United States | Road Runner Research, Ltd. | San Antonio | Texas |
United States | Richmond Behavioral Associates | Staten Island | New York |
United States | University of South Florida Psychiatry and Behavioral Neurosciences | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
MapLight Therapeutics |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of occurrence of treatment-emergent adverse events (TEAEs). | Baseline up to Day 362 | ||
Secondary | Frequency of occurrence of Serious Adverse Events (SAEs) | Baseline up to Day 362 | ||
Secondary | Frequency of occurrence of TEAEs leading to discontinuation. | Baseline up to Day 362 | ||
Secondary | Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments. | Baseline up to Day 362 | ||
Secondary | Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale. | Baseline up to Day 362 |
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