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

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California 90024

from

Los Angeles, CA