NCT00788073

Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome

A Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Seaside Therapeutics, Inc. · Industry
• Sex: All
• Age: 6 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	STX209	Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks
DRUG	Placebo	variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2008-11-10
• Last updated: 2013-05-06
• Results posted: 2013-05-06

Locations

12 sites across 1 country: United States