Conditions: Fragile X Syndrome
Keywords: fragile X syndrome irritability behavior problems
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 63
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks arm 2: variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks

Interventions: intervention 1: STX209 intervention 2: Placebo
Intervention descriptions: intervention 1: Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks intervention 2: variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks

Protocol document: