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ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

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ClinicalTrials.gov Identifier: NCT05889273
Recruitment Status : Enrolling by invitation
First Posted : June 5, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
MapLight Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: ML-004 (IR)/(ER) tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multi-center, open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : June 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ML-004 (IR)/(ER) tablet
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).
 Drug: ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of occurrence of treatment-emergent adverse events (TEAEs). [ Time Frame: Baseline up to Day 362 ]

Secondary Outcome Measures :
  1. Frequency of occurrence of Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 362 ]
  2. Frequency of occurrence of TEAEs leading to discontinuation. [ Time Frame: Baseline up to Day 362 ]
  3. Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments. [ Time Frame: Baseline up to Day 362 ]
  4. Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale. [ Time Frame: Baseline up to Day 362 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 46 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05889273


Locations
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United States, Alabama
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, Arizona
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
United States, Florida
University of South Florida Psychiatry and Behavioral Neurosciences
Tampa, Florida, United States, 33613
United States, Missouri
University of Missouri, Thompson Center for Autism & Neurodevelopment
Columbia, Missouri, United States, 65211
United States, New York
Richmond Behavioral Associates
Staten Island, New York, United States, 10314
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
United States, Texas
Red Oak Psychiatry Associates, PA
Houston, Texas, United States, 77090
Road Runner Research, Ltd.
San Antonio, Texas, United States, 78249
United States, Utah
Cedar Clinical Research
Draper, Utah, United States, 84020
Australia, New South Wales
Brain and Mind Centre
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
The Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria, Australia, 3052
Sponsors and Collaborators
MapLight Therapeutics
More Information
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Additional Information:

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Responsible Party: MapLight Therapeutics
ClinicalTrials.gov Identifier: NCT05889273    
Other Study ID Numbers: ML-004-003
First Posted: June 5, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MapLight Therapeutics:
ASD
Autism
Autism Spectrum Disorder
Social Communication
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders