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ML-004 for Autism

Phase 2

Waitlist Available

Research Sponsored by MapLight Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 362

Awards & highlights

Study Summary

This trial will study the effects of a drug on people with Autism Spectrum Disorder (ASD). Approximately 120 people will take part.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests an oral medication called ML-004 in tablet form, both immediate-release (IR) and extended-release (ER), for individuals with Autism Spectrum Disorder. This extension of an earlier trial aims to gather more data about the drug's long-term effects.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with ASD medications may include sleepiness, stomach upset, changes in appetite or mood swings. The exact side effects will depend on individual reactions to ML-004.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 362

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 362

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 362 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of occurrence of treatment-emergent adverse events (TEAEs).

Secondary outcome measures

Frequency of occurrence of Serious Adverse Events (SAEs)

Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.

Frequency of occurrence of TEAEs leading to discontinuation.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

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).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

MapLight TherapeuticsLead Sponsor

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Autism Research Study Groups: ML-004 (IR)/(ER) tablet

Autism Clinical Trial 2023: ML-004 Highlights & Side Effects. Trial Name: NCT05889273 — Phase 2

Frequently Asked Questions

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

Does my profile meet the requirements for participation in this research?

"Candidates hoping to participate in this study must have been diagnosed with autism spectrum disorder and be between 12 and 45 years of age. At the current moment, recruitment is seeking around 120 people."

Answered by AI

Is the age limit for inclusion in this clinical trial greater than 40 years old?

"This medical experiment is accepting volunteers who are aged between 12 and 45."

Answered by AI

How many volunteers have committed to this experiment?

"Affirmative. Clinicaltrials.gov displays that the trial, which was first advertised on June 1st 2023, is actively looking for participants to enrol in the research. There are 120 positions available at one site."

Answered by AI

Is enrollment currently open for this clinical trial?

"As indicated on clinicaltrials.gov, this medical trial is accepting participants at present. The posting was initially made in June 1st of 2023 and the information has been updated recently as well."

Answered by AI

How potentially harmful is the ML-004 (IR)/(ER) tablet for those taking it?

"The safety of ML-004 (IR)/(ER) tablet is estimated to be a 2 on the scale from 1-3, due to Phase 2 trial data available that indicates some evidence of safety but none related to efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

2023. "ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889273.

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