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RO4917523 Dose A for Fragile X Syndrome

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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights

Study Summary

This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523 or placebo orally daily for 12 weeks.

Eligible Conditions
  • Fragile X Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety: Incidence of adverse events
Secondary outcome measures
Efficacy: Neuropsychological/behavioral assessment scales (ADAMS/Clinical Global Impressions CGI-S, CGI-I/ GBAS/Aberrant Behavior Checklist ABC/Repeatable Battery for the Assessment of Neuropsychological Status RBANS/VAS behavior)
Pharmacokinetics: Clearance (CL/F)
Pharmacokinetics: Volume of distribution at steady-state (Vss/F)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: RO4917523 Dose BExperimental Treatment1 Intervention
Group II: RO4917523 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Basimglurant
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,092,138 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
225 Patients Enrolled for Fragile X Syndrome
Clinical TrialsStudy DirectorHoffmann-La Roche
2,203 Previous Clinical Trials
890,731 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
225 Patients Enrolled for Fragile X Syndrome
~4 spots leftby Jun 2025
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