Seaside Therapeutics initiated a randomized, double-blind, placebo-controlled Phase 3 study to evaluate the effects of STX209 (arbaclofen) on social impairment in adolescents and adults (ages 12 to 25) with fragile X syndrome.
A second study in children (ages 5 to 11) is expected to begin in early summer.
STX209 is an oral selective gamma-amino butyric acid type B (GABA-B) receptor agonist.
The Phase 3 study is expected to involve approximately 20 clinical sites in the United States and enroll 120 subjects. Patients will be randomized to receive STX209 or placebo and then treated over an eight-week period, including up to 28 days of titration followed by stable dosing. Active treatment will be followed by a withdrawal period and a follow-up period. Subjects who complete the entire study may be eligible to enroll in a subsequent open-label study. The study is designed to measure the efficacy, safety and tolerability of STX209.
The primary efficacy endpoint will evaluate social withdrawal.
Release Date: June 2, 2011
Source: Seaside Therapeutics
Filed Under: Drug Discovery