Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
NCT ID: NCT00788073
Last Updated: 2013-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2008-11-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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STX209
STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
STX209
Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks
Placebo
variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Placebo
variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Interventions
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STX209
Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks
Placebo
variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who are currently receiving treatment with racemic baclofen.
* Subjects currently treated with vigabatrin or tiagabine.
* Subjects taking another investigational drug currently or within the last 30 days.
6 Years
40 Years
ALL
No
Sponsors
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Seaside Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Berry-Kravis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Randi Hagerman, MD
Role: PRINCIPAL_INVESTIGATOR
M.I.N.D. Institute
Craig Erikson, MD
Role: PRINCIPAL_INVESTIGATOR
Riley Hospital for Children
Bryan King, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
James McCracken, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Jonathan Picker, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Linmarie Sikich, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina Neurosciences Hospital
Jeremy Veenstra-VanderWeele, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Kennedy Center
Ted Brown, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NYS institute for Basic Research in Developmental Disabilities
Lawrence Ginsberg, MD
Role: PRINCIPAL_INVESTIGATOR
Red Oaks Psychiatry Associates, PA
Shivkumar Hatti, MD
Role: PRINCIPAL_INVESTIGATOR
Suburban Research Associates
Raun Melmed, MD
Role: PRINCIPAL_INVESTIGATOR
Southwest Autism Research & Resource Center
Locations
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Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States
M.I.N.D. Institute
Sacramento, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Hospital Boston
Boston, Massachusetts, United States
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, United States
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States
Suburban Research Associates
Media, Pennsylvania, United States
Vanderbilt Kennedy Center
Nashville, Tennessee, United States
Red Oaks Psychiatry Associates, P.A.
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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22001
Identifier Type: -
Identifier Source: org_study_id
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