A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome

Status:	Completed
Conditions:	Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	May 2011
End Date:	September 2011

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome

The study will consist of a Screening period (up to 14 days), a Treatment period, and a
Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10
or 30 mg (or matching placebo) across four study centers.

Inclusion Criteria:

- Male subjects 18 to 50 years of age, inclusive.

- Molecular documentation of the full fragile X mutation.

Exclusion Criteria:

- Subjects with a history of seizure disorder who are, in the opinion of the
Investigator and Medical Monitor, not currently considered to be well controlled.

- Subjects currently being treated with psychoactive medications (including stimulants
and anxiolytics).

- Subjects with any condition, including alcohol and drug abuse, which might interfere
with the conduct of the study, confound interpretation of the study results, or
endanger their own well-being. 4. Subjects who plan to initiate or change
pharmacologic or non-pharmacologic interventions during the course of the study.

- Subjects who, in the Investigator's opinion, might not be suitable for the study

We found this trial at

sites

Rush University Medical Center

1653 W. Congress Parkway
Chicago, Illinois 60612

(312) 942-5000