Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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

Key facts

Study ID

NCT01325220

Run by

Seaside Therapeutics, Inc.

People needed

172

Starts

2011-06-01

Last updated by the study team

2013-07-31

Who can join

Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Molecular documentation of the full FMR1 mutation
• Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
• Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
• If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

You may not qualify if…

• 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.
• Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
• Subjects who have taken another investigational drug within the last 30 days.
• Subjects who are not able to take oral medications

Where it is running

• 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
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Children's Hospital of Michigan — Detriot, Michigan, United States
• University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders — Columbia, Missouri, United States
• Seaver Autism Center, Mount Sinai Medical Center — New York, New York, United States
• New York State Institute for Basic Research in Developmental Disabilities — Staten Island, New York, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University of Oklahoma, Physician's Child Study Center — Oklahoma City, Oklahoma, United States
• Suburban Research Associates/Elwyn Genetics — Media, Pennsylvania, United States
• Greenwood Genetics Center — Greenwood, South Carolina, United States
• Vanderbilt Kennedy Center — Nashville, Tennessee, United States
• Childrens Medical Center Dallas — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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