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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ML-004 (IR)/(ER) tablet | Experimental | 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). |
|
| ML-004 Placebo | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ML-004 (IR)/(ER) tablet | Drug | Participants will receive ML-004 once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score | 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. | Baseline up to Day 110 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Clinician Global Impression of Improvement (CGI-I) | 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). | Day 110 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | United States | ||
| Southwest Autism Research & Resource Center, Clinical Research |
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Multi-center, randomized, double-blind, placebo-controlled study
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Double-blind
| ML-004 Placebo |
| Drug |
Participants will receive matching placebo once daily. |
|
| Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score | 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). | Baseline up to Day 110 |
| Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score | 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. | Baseline up to Day 110 |
| Change from baseline in the Clinician Global Impression of Severity (CGI-S) Score | 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). | Baseline up to Day 110 |
| Change from baseline in the ABI Repetitive/Restrictive Behavior Domain Score | 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. | Baseline up to Day 110 |
| Change from baseline in the ABI Mood and Anxiety Domain Score | 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. | Baseline up to Day 110 |
| Change from baseline in the ABI Challenging Behavior Domain Score | 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. | Baseline up to Day 110 |
| Change from baseline in the ABI Self-regulation Domain Score | 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. | Baseline up to Day 110 |
| Change from baseline in the ABI-Short Form (ABI-S) Score | 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. | Baseline up to Day 110 |
| Change from baseline in the ABC-Social Withdrawal (ABC-SW) Subscale Score | 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). | Baseline up to Day 110 |
| Change from baseline in the Social Responsiveness Scale 2 (SRS-2) Score | The SRS-2 consists of 65 items across 5 subscales. Responses range from 1 (not true) to 4 (almost always true). | Baseline up to Day 110 |
| Change from baseline in the Vineland-3 (Domain Level Version) Score: total of Communication, Socialization, and Maladaptive behavior domains | The Vineland-3 Domain Level Version contains 5 domains. Responses on each item are rated from 0 (never) to 2 (usually). | Baseline up to Day 110 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Cortica Healthcare | Glendale | California | 91203 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Cortica | San Rafael | California | 94903 | United States |
| Yale Child Study Center | New Haven | Connecticut | 06519 | United States |
| Children's National Health System - The Children's Research Institute (CRI) | Washington D.C. | District of Columbia | 20010 | United States |
| Abba Medical Group | Miami | Florida | 33176 | United States |
| APG Research, LLC | Orlando | Florida | 32803 | United States |
| University of South Florida Psychiatry and Behavioral Neurosciences | Tampa | Florida | 33613 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders | Columbia | Missouri | 65211 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Nathan Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| Center for Autism and the Developing Brain, New York State Psychiatric Institute | White Plains | New York | 10605 | United States |
| Ohio State University Nisonger Center | Columbus | Ohio | 43210 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | United States |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | United States |
| Cedar Clinical Research | Draper | Utah | 84020 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23220 | United States |
| Brain and Mind Centre | Camperdown | New South Wales | 2050 | Australia |
| The Royal Children's Hospital, Murdoch Children's Research Institute | Parkville | Victoria | 3052 | Australia |
| OCT Research ULC (dba Okanagan Clinical Trials) | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Lawson Health Research Institute/ London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G 1R8 | Canada |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D003142 | Communication |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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