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

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

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

Sponsors & Collaborators

• Seaside Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Elizabeth Berry-Kravis, MD, PhD · Rush University Medical Center

• Randi Hagerman, MD · M.I.N.D. Institute

• Craig Erikson, MD · Riley Hospital for Children

• Bryan King, MD, PhD · Seattle Children's Hospital

• James McCracken, MD · University of California, Los Angeles

• Jonathan Picker, MBChB, PhD · Boston Children's Hospital

• Linmarie Sikich, MD · University of North Carolina Neurosciences Hospital

• Jeremy Veenstra-VanderWeele, MD · Vanderbilt Kennedy Center

• Ted Brown, MD, PhD · NYS institute for Basic Research in Developmental Disabilities

• Lawrence Ginsberg, MD · Red Oaks Psychiatry Associates, PA

• Shivkumar Hatti, MD · Suburban Research Associates

• Raun Melmed, MD · Southwest Autism Research & Resource Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2010-03-31

Completion

2010-05-31

Countries

• United States

Study Locations