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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05081245
Registration number
NCT05081245
Ethics application status
Date submitted
5/10/2021
Date registered
18/10/2021
Titles & IDs
Public title
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
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Scientific 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).
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Secondary ID [1]
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ML-004-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
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Condition category
Condition code
Mental Health
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Autistic spectrum disorders
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Mental Health
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Other mental health disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ML-004 (IR)/(ER) tablet
Treatment: Drugs - ML-004 Placebo
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).
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).
Treatment: Drugs: ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
Treatment: Drugs: ML-004 Placebo
Participants will receive matching placebo once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Day 110
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Secondary outcome [1]
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Change from Baseline in Clinician Global Impression of Improvement (CGI-I)
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Assessment method [1]
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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).
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Timepoint [1]
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Day 110
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Secondary outcome [2]
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Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline up to Day 110
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Secondary outcome [3]
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Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline up to Day 110
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Secondary outcome [4]
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Change from baseline in the Clinician Global Impression of Severity (CGI-S) Score
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline up to Day 110
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Secondary outcome [5]
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Change from baseline in the ABI Repetitive/Restrictive Behavior Domain Score
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline up to Day 110
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Secondary outcome [6]
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Change from baseline in the ABI Mood and Anxiety Domain Score
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline up to Day 110
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Secondary outcome [7]
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Change from baseline in the ABI Challenging Behavior Domain Score
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline up to Day 110
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Secondary outcome [8]
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Change from baseline in the ABI Self-regulation Domain Score
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline up to Day 110
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Secondary outcome [9]
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Change from baseline in the ABI-Short Form (ABI-S) Score
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline up to Day 110
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Secondary outcome [10]
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Change from baseline in the ABC-Social Withdrawal (ABC-SW) Subscale Score
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Assessment method [10]
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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).
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Timepoint [10]
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Baseline up to Day 110
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Secondary outcome [11]
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Change from baseline in the Social Responsiveness Scale 2 (SRS-2) Score
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Assessment method [11]
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The SRS-2 consists of 65 items across 5 subscales. Responses range from 1 (not true) to 4 (almost always true).
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Timepoint [11]
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Baseline up to Day 110
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Secondary outcome [12]
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Change from baseline in the Vineland-3 (Domain Level Version) Score: total of Communication, Socialization, and Maladaptive behavior domains
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Assessment method [12]
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The Vineland-3 Domain Level Version contains 5 domains. Responses on each item are rated from 0 (never) to 2 (usually).
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Timepoint [12]
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Baseline up to Day 110
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Eligibility
Key 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
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Minimum age
12
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Maximum age
45
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2025
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Brain and Mind Centre - Camperdown
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Recruitment hospital [2]
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Children's Health Queensland Hospital and Health Service - South Brisbane
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Recruitment hospital [3]
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Mater Research - South Brisbane
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Recruitment hospital [4]
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Flinders Medical Centre - Adelaide
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Recruitment hospital [5]
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The Royal Children's Hospital, Murdoch Children's Research Institute - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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5042 - Adelaide
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Arizona
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United States of America
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California
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United States of America
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State/province [4]
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Connecticut
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Country [5]
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United States of America
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District of Columbia
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Country [6]
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United States of America
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Florida
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Country [7]
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United States of America
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State/province [7]
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Illinois
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Country [8]
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United States of America
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Massachusetts
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Country [9]
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United States of America
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Michigan
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Country [10]
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Missouri
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New Jersey
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Country [12]
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United States of America
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New York
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Country [13]
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United States of America
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Ohio
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Pennsylvania
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State/province [15]
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Texas
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Country [16]
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Utah
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Washington
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Country [18]
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Canada
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State/province [18]
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British Columbia
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Country [19]
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Canada
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State/province [19]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
MapLight Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05081245
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alexis Levine
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Address
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Phone
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+1 650-839-4388
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05081245