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Completed Phase 2 Interventional

A Study of RO4917523 in Patients With Fragile X Syndrome

ClinicalTrials.gov ID: NCT01517698

Public ClinicalTrials.gov record NCT01517698. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01517698
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
185 participants

Conditions and interventions

Eligibility (public fields only)

Age range
14 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2012 (Type not available)
Primary completion
Apr 2014 (Actual)
Completion
Apr 2014 (Actual)
Last update posted
Jul 11, 2016

2012 – 2014

United States locations

U.S. sites
20
U.S. states
17
U.S. cities
20
Facility City State ZIP Site status
Not listed Phoenix Arizona 85006 —
Not listed Long Beach California 90806 —
Not listed Sacramento California 95817 —
Not listed Aurora Colorado 80045 —
Not listed Washington D.C. District of Columbia 20010 —
Not listed Decatur Georgia 30033 —
Not listed Chicago Illinois 60612 —
Not listed Iowa City Iowa 52242-1083 —
Not listed Louisville Kentucky 40202 —
Not listed Baltimore Maryland 21205 —
Not listed Worcester Massachusetts 01655 —
Not listed New York New York 10029 —
Not listed Staten Island New York 10314 —
Not listed Durham North Carolina 27710 —
Not listed Cincinnati Ohio 45229 —
Not listed Media Pennsylvania 19063 —
Not listed Nashville Tennessee 37203 —
Not listed Houston Texas 77030 —
Not listed San Antonio Texas 78258 —
Not listed Seattle Washington 98145 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01517698, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 11, 2016 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01517698 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →