At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
STX209 +1 moredrug
Likely dose
STX209 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating STX209 and Placebo for Fragile X Syndrome. Completed, enrolled 63 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionMar 2010
Study CompletionMay 2010
TodayJul 2026
First PostedNov 10, 2008
Enrollment StartNov 1, 2008
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.6 years ago
Interventions
STX209drug
Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks
Placebodrug
variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks