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
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 40
Healthy Volunteers: No
View:

• Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age

• Molecular documentation of the fragile X mutation.

• Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate or higher at screening and at Visit 1

• An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score >12 and at least 3 items on the Irritability Subscale rated at least moderate or above.

• Current treatment with no more than three psychoactive medications, including anti-epileptics.

• Current pharmacological treatment regimen has been stable for at least 4 weeks.

Locations
United States
Arizona
Southwest Autism Research & Resource Center
Phoenix
California
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles
M.I.N.D. Institute
Sacramento
Illinois
Rush University Medical Center
Chicago
Indiana
Riley Hospital for Children
Indianapolis
Massachusetts
Children's Hospital Boston
Boston
North Carolina
University of North Carolina Neurosciences Hospital
Chapel Hill
New York
NYS Institute for Basic Research in Developmental Disabilities
Staten Island
Pennsylvania
Suburban Research Associates
Media
Tennessee
Vanderbilt Kennedy Center
Nashville
Texas
Red Oaks Psychiatry Associates, P.A.
Houston
Washington
Seattle Children's Hospital
Seattle
Time Frame
Start Date: November 2008
Completion Date: May 2010
Participants
Target number of participants: 63
Treatments
Active Comparator: STX209
STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
Placebo Comparator: Placebo
variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Authors
Raun Melmed, Jonathan Picker, Lawrence Ginsberg, Bryan King, Shivkumar Hatti, Linmarie Sikich, Jeremy Veenstra-VanderWeele, James McCracken, Randi Hagerman, Craig Erikson, Ted Brown, Elizabeth Berry-Kravis
Related Therapeutic Areas
Sponsors
Leads: Seaside Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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