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NCT05081245 · ClinicalTrials.gov registry record · Phase 2
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
A Phase 2 study of Autism Spectrum Disorder, sponsored by MapLight Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT05081245: Active Phase 2 study of Autism Spectrum Disorder, sponsored by MapLight Therapeutics.
NCT05081245 is a Phase 2 study of Autism Spectrum Disorder that is active but no longer recruiting, run by MapLight Therapeutics. The registered enrollment target is 150 participants, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081245, a Phase 2 study of Autism Spectrum Disorder, is active but no longer recruiting, sponsored by MapLight Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG ML-004 (IR)/(ER) tablet
- DRUG ML-004 Placebo
Study Locations (20)
California
- Cortica Healthcare - Glendale
- NRC Research Institute - Orange
- Cortica - San Rafael
Florida
- Abba Medical Group - Miami
- APG Research, LLC - Orlando
- University of South Florida Psychiatry and Behavioral Neurosciences - Tampa
New York
- Nathan Kline Institute for Psychiatric Research - Orangeburg
- Richmond Behavioral Associates - Staten Island
- Center for Autism and the Developing Brain, New York State Psychiatric Institute - White Plains
Texas
- BioBehavioral Research of Austin - Austin
- Red Oak Psychiatry Associates, PA - Houston
Alabama
- Harmonex Neuroscience Research - Dothan
Arizona
- Southwest Autism Research & Resource Center, Clinical Research - Phoenix
Connecticut
- Yale Child Study Center - New Haven
District of Columbia
- Children's National Health System - The Children's Research Institute (CRI) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT05081245 still lists
NCT05081245 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which ML-004 (IR)/(ER) tablet is the first listed.
NCT05081245 names 20 study sites across 13 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT05081245 about?
NCT05081245 is a clinical study titled "ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)". 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 def...
What is the current status of trial NCT05081245?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2022-09-13. Estimated completion is 2026-11.
What conditions does trial NCT05081245 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT05081245?
The interventions under investigation include: ML-004 (IR)/(ER) tablet (DRUG), ML-004 Placebo (DRUG).
Who is sponsoring clinical trial NCT05081245?
This trial is sponsored by MapLight Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05081245 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05081245's enrollment target sits among peer trials
150 54th of 224 higher than 170 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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