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Fragile X Study: Long-Term Safety and Efficacy of Investigational Drug (Adolescent)

Clinical Trial Title: 
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of an Investigational Drug in Adolescents With Fragile X Syndrome
Clinical Trial Protocol ID: 
11100402
Clinical Trial Investigator Name: 
Elizabeth Berry-Kravis, MD
Clinical Trial Protocol Description: 

The purpose of this study is to find out whether an experimental drug is safe and effective for treating fragile X syndrome symptoms, when taken for as long as 24 months or until the drug becomes available on the market (whichever occurs later). All study subjects will be treated with the active investigational drug for the entire study, and there will be no placebo.

This product is an investigational drug that is not approved for use for the treatment of people with fragile X syndrome by the U.S. Food and Drug Administration.

This product is a drug that blocks the so-called mGluR5 receptor in the brain. A receptor can be thought of as a "lock" and this drug as a "key" that fits into the lock to stop it from being active. This drug can block the mGluR5 receptor that has increased activity in fragile X patients. By blocking this receptor, it is thought that the symptoms of fragile X syndrome may be reduced.

Clinical Trial Eligibility Criteria: 

You may be eligible to participate in this study if you:

  • Are an individual who participated in the earlier 2214 placebo-controlled study

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided.

Clinical Trial Area: 
Pediatric Neurological Disorders
Contact Phone: 
(312) 942-7250
Contact Name: 
Crystal Hervey