Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01517698 · ClinicalTrials.gov registry record · Phase 2

A Study of RO4917523 in Patients With Fragile X Syndrome

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
185
Enrollment target

NCT01517698: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT01517698 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 185 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01517698, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
185 participants
Enrollment target

Study Summary

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

Interventions

  • DRUG Placebo
  • DRUG RO4917523 0.5 mg
  • DRUG RO4917523 1.5 mg

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 2012-05
Est. Completion 2014-04
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT01517698 record still lists

NCT01517698 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01517698 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01517698 about?

NCT01517698 is a clinical study titled "A Study of RO4917523 in Patients With Fragile X Syndrome". This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placeb...

What is the current status of trial NCT01517698?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2012-05. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01517698?

The interventions under investigation include: Placebo (DRUG), RO4917523 0.5 mg (DRUG), RO4917523 1.5 mg (DRUG).

Who is sponsoring clinical trial NCT01517698?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01517698's enrollment target sits among peer trials

185 357th of 2000 higher than 1,641 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04041154 · 185 participants · NA

    Behavioral and Neural Representations of Subjective Effort Cost

  • NCT04484272 · 185 participants · NA

    A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease

  • NCT05020860 · 185 participants · Phase 2

    Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

  • NCT05793541 · 185 participants · NA

    Just-in-time Interventions for Reducing Short-term Suicide Risk

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01517698, the US trial registry maintained by the National Library of Medicine. NCT01517698 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.