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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 days 14, 42, 84, 98, 126
Awards & highlights

Study Summary

This trial will study if a new drug is effective, safe, and well tolerated in people with ASD aged 15-45 years.

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.Check my eligibility
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.See study design
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.
Select...
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 weeks
Treatment ~ Varies
Follow Up ~days 14, 42, 84, 98, 126
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 14, 42, 84, 98, 126 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 to Week 12 in the Adaptive Behavior Composite score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Secondary outcome measures
Change from Baseline Over Time in Suicide Risk Using the Columbia-Suicide-Severity Rating Scale (C-SSRS)
Change from Baseline to Week 12 in Behavior/Symptoms as Measured by all Domains of the Repetitive Behavior Scale-Revised (RBS-R)
Change from Baseline to Week 12 on the Vineland-3 Socialization Domain
+4 more

Side effects data

From 2018 Phase 1 trial • 6 Patients • NCT03507569
100%
Catheter site pain
50%
Catheter site paraesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
RO7017773 - 15mg
RO7017773 - 75mg
RO7017773 - 375mg
RO7017773 - 30mg

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 1
~20

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,951 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
1,140 Patients Enrolled for Autism Spectrum Disorder
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,399 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
1,134 Patients Enrolled for Autism Spectrum Disorder

Media Library

RO7017773 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04299464 — Phase 2
Autism Spectrum Disorder Research Study Groups: Placebo, RO7017773 Low Dose, RO7017773 High Dose
Autism Spectrum Disorder Clinical Trial 2023: RO7017773 Highlights & Side Effects. Trial Name: NCT04299464 — Phase 2
RO7017773 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04299464 — Phase 2

Frequently Asked Questions

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

Is this research program including participants aged 55 and older?

"This clinical trial is searching for individuals aged between 15 and 45 years old."

Answered by AI

Are there any opportunities presently open for participants in this medical trial?

"According to clinicaltrials.gov, this research study is presently recruiting participants since its initial post on March 31st 2021 and last revision dated November 8th 2022."

Answered by AI

What adverse effects could be potentially caused by RO7017773?

"Data surrounding RO7017773's safety is moderate, so our team gave it a score of 2. This is because the compound has been through Phase 2 testing without any evidence for effectiveness yet."

Answered by AI

Who is qualified to participate in this clinical experiment?

"This research is enrolling 105 participants, ranging from 15 to 45 years old that have been diagnosed with a pervasive developmental disorder. In order for them to be considered eligible, they must answer the following questions: What is their height in inches?; How much do they weigh in pounds?; Are they officially diagnosed by an expert (physician or psychologist)?; Do they often exhibit autism symptoms (e.g., difficulty maintaining eye contact)?; Is there someone willing to provide assistance during the study's execution?, Have a body mass index between 18.5 and 40 kg/m2.; Be capable of adhering strictly to the protocol"

Answered by AI

What is the cap on the total number of volunteers engaged in this trial?

"The study sponsor, Hoffmann-La Roche, demands a total of 105 eligible participants to proceed. The locations currently chosen are the Southwest Autism Research & Resource Center in Phoenix and Nathan Kline Institute in Orangeburg."

Answered by AI

How many sites are hosting this research project?

"This clinical trial has 12 sites to recruit patients, among them the Southwest Autism Research & Resource Center in Phoenix, Nathan Kline Institute in Orangeburg, and Vanderbilt Medical Center in Nashville. Additionally there are 9 other locations accepting participants."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Arizona
Other
New York
How old are they?
65+
18 - 65
< 18
What site did they apply to?
A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti
Montefiore Medical Center
Other
Southwest Autism Research & Resource Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)
2021. "A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04299464.
All > Autism New York
~0 spots leftby May 2024
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