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ML-004 for Autism Spectrum Disorder

Phase 2
Recruiting
Research Sponsored by MapLight Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12 to 45 at screening
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 110
Awards & highlights

Study Summary

This trial is testing a possible new treatment for ASD. It is comparing it to a placebo (fake treatment) to see if it is effective.

Who is the study for?
This trial is for adolescents and adults aged 12 to 45 with Autism Spectrum Disorder (ASD) who can swallow pills. Participants need a care partner to report on symptoms, an IQ score of at least 70, and stable use of psychoactive meds for the past month. Excluded are those with certain other disorders, recent seizures or study participation, history of severe suicidal thoughts or actions, uncontrolled high blood pressure, or if pregnant/lactating.Check my eligibility
What is being tested?
The study tests ML-004 in tablet form against a placebo to see its effects on ASD. It's randomized meaning participants are put into the ML-004 or placebo group by chance and double-blind so neither researchers nor participants know who gets what treatment until after the results are collected.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions similar to other medications affecting mood or cognition such as headaches, nausea, sleep disturbances or behavioral changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 110
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 110 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score
Secondary outcome measures
Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score
Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score
Change from Baseline in Clinician Global Impression of Improvement (CGI-I)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ML-004 (IR)/(ER) tabletExperimental Treatment1 Intervention
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).
Group II: ML-004 PlaceboPlacebo Group1 Intervention
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).

Find a Location

Who is running the clinical trial?

MapLight TherapeuticsLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
120 Patients Enrolled for Autism Spectrum Disorder

Media Library

ML-004 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05081245 — Phase 2
Autism Spectrum Disorder Research Study Groups: ML-004 (IR)/(ER) tablet, ML-004 Placebo
Autism Spectrum Disorder Clinical Trial 2023: ML-004 Highlights & Side Effects. Trial Name: NCT05081245 — Phase 2
ML-004 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081245 — Phase 2
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT05081245 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ML-004 (IR)/(ER) tablet received federal approval for use?

"While there is some data supporting the safety of ML-004, it received a score of 2 because this drug has not yet been proven effective in clinical trials."

Answered by AI

How many individuals are being asked to participate in this clinical trial?

"That is correct, the online registry clinicaltrials.gov has this trial listed as currently recruiting patients. The study began advertising for participants on 8/11/2022 with the most recent update being on 8/24/2022. They are looking to enroll 150 individuals at 2 sites total."

Answered by AI

Are there any patients currently enrolled in this trial?

"As of today, this study is still recruiting patients as seen on clinicaltrials.gov. The trial was first posted on 8/11/20 and has since been edited once on 8/24/22."

Answered by AI

To whom is this clinical test available?

"This research is open to any patients that have an autism spectrum disorder and are between 12-45 years old. In total, there 150 spots available for participants."

Answered by AI

Are people who are middle-aged being accepted for this trial?

"The age requirement for this particular trial is 12-45. There are 438 other trials for children and 666 for seniors."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Other
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Harmonex Neuroscience Research
Richmond Behavioral Associates
Other
Road Runner Research, Ltd.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've recently been diagnosed with ASD (April 2022) and trying to make up the deficits I've lacked for 24 years.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
2022. "ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081245.
All > Asd > Autism
~55 spots leftby Mar 2025
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