A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

ClinicalTrials.gov ID: NCT01750957

Public ClinicalTrials.gov record NCT01750957. 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.

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Official title

A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

Brief summary

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

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.

Study identification

NCT ID: NCT01750957
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 47 participants

Conditions and interventions

Conditions

Fragile X Syndrome

Interventions

Placebo Drug
RO4917523 Drug

Drug

Eligibility (public fields only)

Age range: 5 Years to 13 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: Feb 2013 (Type not available)
Primary completion: Apr 2014 (Actual)
Completion: Apr 2014 (Actual)
Last update posted: Aug 11, 2016

2013 – 2014

United States locations

U.S. sites: 20
U.S. states: 17
U.S. cities: 20

Facility	City	State	ZIP	Site status
Not listed	Long Beach	California	90806	—
Not listed	Sacramento	California	95817	—
Not listed	San Diego	California	92108	—
Not listed	Aurora	Colorado	80045	—
Not listed	Washington D.C.	District of Columbia	20020	—
Not listed	Decatur	Georgia	30033	—
Not listed	Chicago	Illinois	60612	—
Not listed	Iowa City	Iowa	52242	—
Not listed	Louisville	Kentucky	40202	—
Not listed	Baltimore	Maryland	21205	—
Not listed	Worcester	Massachusetts	01605	—
Not listed	Omaha	Nebraska	68198-4160	—
Not listed	New York	New York	10029	—
Not listed	Cincinnati	Ohio	45229	—
Not listed	Media	Pennsylvania	19063	—
Not listed	Greenwood	South Carolina	29646	—
Not listed	Nashville	Tennessee	37212	—
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.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01750957, 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 Aug 11, 2016 · Synced Nov 9, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01750957 live on ClinicalTrials.gov.

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