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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 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.

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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).

Conditions Studied

Autism Spectrum Disorder (ASD)

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

FieldValue
Enrollment Target 104 participants
Start Date 2021-03-31
Est. Completion 2024-05-15
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT04299464

The ClinicalTrials.gov registry entry for NCT04299464 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 96-participant average among 16 other Autism Spectrum Disorder (ASD) trials with a reported enrollment target. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.