A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO701… (NCT04299464) | Clinical Trial Compass
CompletedPhase 2
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)
United States104 participantsStarted 2021-03-31
Plain-language summary
This study will investigate the efficacy, safety, tolerability, and pharmacokinetics of RO7017773 in participants aged 15-45 years who have been diagnosed with ASD with a score of \>/=50 on the Wechsler Abreviated Scale of Intelligence (WASI-II).
Who can participate
Age range15 Years – 45 Years
SexALL
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Inclusion Criteria
* Male and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Wechsler Abbreviated Scale of Intelligence (WASI-II) \>/= 50 at screening or within the last 12 months prior to screening
* ASD or Autism diagnosis confirmed by Autism Diagnostic Observation Schedule (ADOS-2)
* Body mass index within the range of 18.5 to 40 kg/m2
* Female Participants: is eligible if she is not pregnant, not breastfeeding, and women of childbearing potential (WOCBP), who agree to remain abstinent or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 28 days after the last dose of study drug
* Language, hearing, and vision compatible with the study measurements as judged by the Investigator
* Allowed existing treatment regimens should be stable for 8 weeks prior to screening. Investigator expects stability of these treatments and behavioral interventions for the duration of the study
* In the Investigator's opinion, able to participate and deemed appropriate for participation in the study, capable of following the study SoA and able to comply with the study restrictions
* In the Investigator's opinion, participation in the study or discontinuation of prohibited medication will not pose undue risks
Exclusion Criteria
Neurologic/Psychiatric Conditions:
* Non-verbal individuals
* Presence of chromosome 15q11.2 q13.1 duplica…
What they're measuring
1
Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)