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A Study of RO4917523 in Patients With Fragile X Syndrome

NCT01517698 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2016-07-11

No results posted yet for this 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.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

Placebo

placebo to RO4917523 orally once a day for 12 weeks

DRUG

RO4917523 0.5 mg

0.5 mg orally once a day for 12 weeks

DRUG

RO4917523 1.5 mg

1.5 mg orally once a day for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • France
  • Mexico
  • Peru
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517698 on ClinicalTrials.gov