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NCT04299464 · ClinicalTrials.gov registry record · Phase 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)
A Phase 2 study of Autism Spectrum Disorder (ASD), sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT04299464: Completed Phase 2 study of Autism Spectrum Disorder (ASD), sponsored by Hoffmann-La Roche.
NCT04299464 is a Phase 2 study of Autism Spectrum Disorder (ASD) that has completed, run by Hoffmann-La Roche. The registered enrollment target is 104 participants, roughly in line with the 96-participant average among 16 other Autism Spectrum Disorder (ASD) trials with a reported enrollment target. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04299464, a Phase 2 study of Autism Spectrum Disorder (ASD), has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Vineland-3 is a semi-structured interview that measures an individual's adaptive behavior across 3 domains: Communication, Socialization, and Daily Living skills. Each domain is composed of 3 subdomains. Subdomain raw score is based on item responses (3-point scale: 0=never present; 1=sometimes present; 2=usually present) and is calculated for each subdomain of the three main domains as the sum of the scores for each item within the subdomain. Raw scores of the 9 subdomains are used to derive Gr
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO7017773
Study Locations (20)
New York
- Nathan Kline Institute - Orangeburg
- Montefiore Medical Center - The Bronx
Ohio
- University Hospitals - Cleveland
- Ohio State University - Columbus
Ontario
- Holland Bloorview Kids Rehabilitation Hospital - East York
- London Health Sciences Centre - London
Other
- IGAIN (Instituto Global de Atención Integral al Neurodesarrollo) - Barcelona
- Hospital Universitari Vall d'Hebron - Barcelona
Arizona
- Southwest Autism Research and Resource Center - Phoenix
Connecticut
- Yale University / Yale-New Haven Hospital - New Haven
Florida
- APG- Advanced Psychiatric Group - Orlando
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2021-03-31 |
| Est. Completion | 2024-05-15 |
| Phase | Phase 2 |
What the finished NCT04299464 record still lists
NCT04299464 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 96-participant average among 16 other Autism Spectrum Disorder (ASD) trials with a reported enrollment target.
The record links to 1 condition, with Autism Spectrum Disorder (ASD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04299464 names 20 study sites across 16 states, led by New York, Ohio, Ontario.
Frequently Asked Questions
What is clinical trial NCT04299464 about?
NCT04299464 is a clinical study titled "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)". 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).
What is the current status of trial NCT04299464?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2021-03-31. Estimated completion is 2024-05-15.
What conditions does trial NCT04299464 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder (ASD).
What interventions are being tested in trial NCT04299464?
The interventions under investigation include: Placebo (DRUG), RO7017773 (DRUG).
Who is sponsoring clinical trial NCT04299464?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04299464 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04299464's enrollment target sits among peer trials
104 6th of 16 higher than 11 of 16 other Autism Spectrum Disorder (ASD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder (ASD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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