What side effects are associated with this type of intervention?

Common pharmacologic treatments for Autism Spectrum Disorder (ASD) include antipsychotics like risperidone and aripiprazole, which can cause side effects such as weight gain, drowsiness, increased appetite, fatigue, and extrapyramidal symptoms. Selective serotonin reuptake inhibitors (SSRIs) and stimulants, used off-label, may cause gastrointestinal disturbances, sleep problems, and increased anxiety. Novel agents like RO7017773, currently under investigation, may have a different side effect profile, which would be detailed in clinical trial data.

What prior FDA approvals exist?

As of now, the FDA has not approved any drugs specifically targeting the core symptoms of Autism Spectrum Disorder (ASD). Current FDA-approved treatments for ASD primarily address associated symptoms such as irritability. For example, Risperidone and Aripiprazole are approved to treat irritability in children with ASD. RO7017773, being investigated for its efficacy, safety, and tolerability in ASD, represents a novel approach potentially targeting specific pathways involved in the disorder, which could offer new therapeutic options if proven effective.

What other types of research exist?

Promising, novel alternatives to RO7017773 for Autism Spectrum Disorder (ASD) patients in 2024 may include: 1) Oxytocin and vasopressin receptor modulators, which are being studied for their potential to improve social functioning in ASD. 2) Arbaclofen, a GABA-B receptor agonist, which has shown promise in improving social behaviors and reducing anxiety. 3) Bumetanide, a diuretic that may help reduce core symptoms of ASD by modulating neurotransmitter systems. 4) Behavioral and cognitive therapies, which continue to evolve and show efficacy in managing ASD symptoms. Patients should discuss these options with their healthcare provider to determine the best course of action.

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RO7017773 for Autism Spectrum Disorder

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Male and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

Do you frequently experience autism symptoms (ex: difficulty maintaining eye contact)?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug called RO7017773 to see if it can help people aged 15-45 with Autism Spectrum Disorder (ASD) who have a certain level of intelligence. The study will check how well the drug works, how safe it is, and how the body handles it.

Who is the study for?

This trial is for individuals aged 15-45 with Autism Spectrum Disorder (ASD), who score at least 50 on the WASI-II intelligence test, have a BMI of 18.5 to 40 kg/m2, and experience autism symptoms. Participants must have a supportive caretaker and be able to follow study procedures without undue risk.

What is being tested?

The trial tests RO7017773's effectiveness and safety compared to a placebo over 12 weeks in treating ASD. It will also look into how the body processes the drug.

What are the potential side effects?

While specific side effects are not listed, common ones may include digestive issues, headaches, sleep disturbances or mood changes. The study aims to assess overall safety and tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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The text discusses male and female participants who have Autism Spectrum Disorder as classified by the DSM-5.

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You have trouble making eye contact or other symptoms associated with autism.

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Your body mass index (BMI) falls within the range of 18.5 to 40 kg/m2.

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Will someone be able to help take care of you during the study?

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An expert has diagnosed you with autism.

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My doctor thinks I can follow the study's requirements.

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The study team has determined that participating in the research or stopping certain medications will not harm your health.

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I know my height in inches.

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What is your weight in pounds?

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

Side effects data

From 2018 Phase 1 trial • 6 Patients • NCT03507569

50%

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

RO7017773 - 75mg

RO7017773 - 15mg

RO7017773 - 30mg

RO7017773 - 375mg

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: RO7017773 Low DoseExperimental Treatment1 Intervention

Participants will receive a fixed low dose of RO7017773 for approximately 12 weeks.

Group II: RO7017773 High DoseExperimental Treatment1 Intervention

Participants will receive a fixed high dose of RO7017773 for approximately 12 weeks.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matched to RO7017773 for approximately 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RO7017773

2018

Completed Phase 2

~130

0 / 9Eligibility criteria met

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 neurotransmitter systems to alleviate symptoms. For example, selective serotonin reuptake inhibitors (SSRIs) are used to manage anxiety and repetitive behaviors by increasing serotonin levels in the brain. Antipsychotic medications, such as risperidone and aripiprazole, target dopamine and serotonin receptors to reduce irritability and aggression. Novel therapeutic agents like RO7017773 may focus on modulating specific neural pathways implicated in ASD, potentially offering more targeted and effective symptom management. Understanding these mechanisms is crucial for developing treatments that address the core symptoms of ASD, improving the quality of life for patients.

Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.[Good practice guidelines for the treatment of autistic spectrum disorders].