ML-004 for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety of an experimental treatment called ML-004 for individuals with Autism Spectrum Disorder (ASD). The treatment involves taking a specially designed tablet once a day, which releases medication immediately and gradually in the stomach. This study is open to individuals who have completed a previous related study and have an ASD diagnosis. Participants should have stable psychoactive medications and be able to swallow pills. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that any psychoactive medications and therapies be stable for 4 weeks before starting, so you may need to keep your current medications unchanged during this time.
Is there any evidence suggesting that ML-004 is likely to be safe for humans?
Research shows that ML-004 is under investigation for safety in individuals with Autism Spectrum Disorder (ASD). These studies have assessed the safety and tolerability of ML-004. Earlier research tested ML-004 on adults and teenagers with ASD to evaluate their response to the treatment.
While specific safety data on ML-004 remains limited, a similar medication, aripiprazole, has been studied and is used for conditions related to ASD, providing some insight into ML-004's potential safety. The trial's second phase indicates that ML-004 demonstrated some safety in earlier studies, but further information is necessary. Participants might experience mild to moderate side effects, but the treatment is generally considered well tolerated based on similar drugs.12345Why do researchers think this study treatment might be promising for autism?
Unlike standard treatments for autism, which often include behavioral therapies and medications like antipsychotics and stimulants, ML-004 offers a novel approach with its bilayer immediate-release and extended-release tablet. This unique formulation allows for a more controlled and sustained release of the medication, potentially leading to more consistent therapeutic effects throughout the day. Researchers are excited about ML-004 because its dual-action delivery could improve symptom management by providing both an immediate and prolonged effect, which is not typically available with current treatment options.
What evidence suggests that ML-004 might be an effective treatment for ASD?
Research has shown that ML-004 may improve social communication skills in people with autism spectrum disorder (ASD). In studies comparing ML-004 to a placebo, participants taking ML-004 demonstrated noticeable improvements in social interactions. Early animal studies suggested that ML-004 might increase sociability and decrease aggression. While more research is needed to confirm these effects in humans, these early results are promising.12346
Are You a Good Fit for This Trial?
This trial is for adolescents and adults aged 12 to 45 with Autism Spectrum Disorder who finished study ML-004-002 within the last 90 days. Participants must have a stable body weight, be on consistent psychoactive medications or therapies for at least four weeks, and be able to swallow pills. They also need a reliable care partner to report on their symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants receive ML-004 in an open-label extension to evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ML-004
Find a Clinic Near You
Who Is Running the Clinical Trial?
MapLight Therapeutics
Lead Sponsor