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ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

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ClinicalTrials.gov Identifier: NCT05081245
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
MapLight Therapeutics

Study Description
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Brief Summary:
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, randomized, double-blind, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Actual Study Start Date : September 13, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


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.
Placebo Comparator: ML-004 Placebo
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).
 Drug: ML-004 Placebo
Participants will receive matching placebo once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score [ Time Frame: Baseline up to Day 110 ]
    Change from baseline in the ABI-Social Communication Domain Score will be reported. The ABI is a 62-item questionnaire for reporting the behaviors of subjects (ages: 3 years-adulthood) diagnosed with ASD. The tool is suitable for completion by parents or care/study partners of people with ASD. Each item assesses either quality (from not at all to without help) or frequency (never to very often) of a particular behavior. The Social Communication domain score is the sum of the scores in the social communication domain divided by the number of items in the domain.


Secondary Outcome Measures :
  1. Change from Baseline in Clinician Global Impression of Improvement (CGI-I) [ Time Frame: Day 110 ]
    The CGI-I score is a single-item instrument based on a 7-point scale routinely used in clinical trials to capture the Investigator's global impression of response. The Investigator or designee rates the improvement observed from 1 (very much improved) to 7 (very much worse).

  2. Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score [ Time Frame: Baseline up to Day 110 ]
    The ABI-Clinician (ABI-C) captures the clinician rating of behaviors of a person with ASD that occurred over the week prior to assessment. It contains 14 items reflecting the core and associated autism behavior domains: Social Communication, Restrictive Behaviors, Mood and Anxiety, Self Regulation, and Challenging Behavior. Each item is rated on a 7-point scale from 1 (none; no symptoms present) to 7 (very severe; persistent interference with function or adaptation).

  3. Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score [ Time Frame: Baseline up to Day 110 ]
    The ABC is a parent- or care/study partner-reported behavior rating assessment with five domains and 58 items, each rated on a 0 (not at all a problem) to 3 (the problem is severe in degree) scale. The irritability domain consists of 15 items.

  4. Change from baseline in the Clinician Global Impression of Severity (CGI-S) Score [ Time Frame: Baseline up to Day 110 ]
    The CGI-S is a global assessment of the clinician-rater's impression of the severity of the participant's illness. It is rated on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).

  5. Change from baseline in the ABI Repetitive/Restrictive Behavior Domain Score [ Time Frame: Baseline up to Day 110 ]
    Each item on the ABI-Repetitive/Restrictive Behavior Domain is rated by frequency (never to very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.

  6. Change from baseline in the ABI Mood and Anxiety Domain Score [ Time Frame: Baseline up to Day 110 ]
    Each item on the ABI- Mood and Anxiety Domain is rated by frequency (never to very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.

  7. Change from baseline in the ABI Challenging Behavior Domain Score [ Time Frame: Baseline up to Day 110 ]
    Each item on the ABI- Challenging Behavior Domain is rated by frequency (never to very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.

  8. Change from baseline in the ABI Self-regulation Domain Score [ Time Frame: Baseline up to Day 110 ]
    Each item on the ABI- Self-regulation Domain is rated by frequency (never to very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.

  9. Change from baseline in the ABI-Short Form (ABI-S) Score [ Time Frame: Baseline up to Day 110 ]
    The ABI-S is a 24-item short version of the ABI, containing items from each of the five domains. The domain score for each domain is calculated as the sum of scores all domain items divided by the number of items in the domain.

  10. Change from baseline in the ABC-Social Withdrawal (ABC-SW) Subscale Score [ Time Frame: Baseline up to Day 110 ]
    The ABC-SW subscale consists of 16 items of the ABC-2 rated from 0 (not at all a problem) to 3 (the problem is severe in degree).

  11. Change from baseline in the Social Responsiveness Scale 2 (SRS-2) Score [ Time Frame: Baseline up to Day 110 ]
    The SRS-2 consists of 65 items across 5 subscales. Responses range from 1 (not true) to 4 (almost always true).

  12. Change from baseline in the Vineland-3 (Domain Level Version) Score: total of Communication, Socialization, and Maladaptive behavior domains [ Time Frame: Baseline up to Day 110 ]
    The Vineland-3 Domain Level Version contains 5 domains. Responses on each item are rated from 0 (never) to 2 (usually).


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Has a body mass index (BMI) 18 through 34 kg/m², inclusive
  • Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
  • 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 ≥140 mmHg (if adult) or >135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or >85 mmHg (if adolescent), or 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): NCT05081245


Contacts
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Contact: Alexis Levine +1 650-839-4388 alevine@maplightrx.com

Locations
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Sponsors and Collaborators
MapLight Therapeutics
More Information
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Responsible Party: MapLight Therapeutics
ClinicalTrials.gov Identifier: NCT05081245    
Other Study ID Numbers: ML-004-002
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: May 1, 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