What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include melatonin, omega-3 fatty acids, and N-acetyl cysteine. Melatonin is generally well-tolerated, with side effects including drowsiness, headache, and dizziness. Omega-3 fatty acids may cause gastrointestinal distress such as nausea and diarrhea, and should be used cautiously in patients with bleeding disorders. N-acetyl cysteine has not shown significant benefits in treating ASD and may have adverse events similar to placebo. Overall, these treatments are considered to have low risk but their efficacy in treating core symptoms of ASD remains uncertain.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of symptoms associated with Autism Spectrum Disorder (ASD), although no specific drug is approved to treat the core symptoms of ASD itself. Risperidone and aripiprazole are two antipsychotic medications approved for treating irritability associated with ASD in children and adolescents. These drugs primarily work by modulating dopamine and serotonin receptors. The ML-004 trial focuses on evaluating the safety of a treatment for ASD, but specific details about the mechanism of action of the treatment being studied in ML-004 are not provided. Therefore, it is essential to consult with a healthcare provider for the most appropriate treatment options.

What other types of research exist?

The provided context does not mention any specific alternatives to ML-004 for the treatment of Autism Spectrum Disorder (ASD). Therefore, it is recommended to consult with a healthcare provider for the most current and suitable treatment options available in 2024.

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Other

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of a treatment called ML-004 in adolescents and adults with Autism Spectrum Disorder (ASD). The main goal is to ensure that the treatment does not cause any harmful side effects.

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) often target the core symptoms such as social-communication difficulties and repetitive behaviors. Pharmacological treatments, including antipsychotics and selective serotonin reuptake inhibitors (SSRIs), work by modulating neurotransmitter systems like dopamine and serotonin, which are believed to be dysregulated in ASD. Behavioral interventions, such as Applied Behavior Analysis (ABA), focus on reinforcing desired behaviors and reducing harmful ones through structured activities. These mechanisms are crucial as they aim to alleviate the core symptoms of ASD, thereby improving the quality of life and functional abilities of patients.

Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.Neural Mechanisms of Qigong Sensory Training Massage for Children With Autism Spectrum Disorder: A Feasibility Study.Neurologic treatment strategies in autism: an overview of medical intervention strategies.