There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale
This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal
Time frame: at 8 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
Miller Children's Hospital
Long Beach, California, United States
University of California-Davis, M.I.N.D. Institute
Sacramento, California, United States
Psychiatric Centers at San Diego
San Diego, California, United States
University of Colorado Denver, Children's Hospital
Aurora, Colorado, United States
University of Miami, Mailman Center for Child Development
Miami, Florida, United States
Lake Mary Pediatrics
Orange City, Florida, United States
Emory University School of Medicine
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kansas University Clinical Research Center
Fairway, Kansas, United States
...and 18 more locations