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



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2011
End Date:August 2013
Contact:Craig Penz
Email:cpenz@seasidetherapeutics.com
Phone:617-374-9009

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A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome


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


Inclusion Criteria:

- 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

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.

- 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
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1648 Pierce Dr NE
Atlanta, Georgia 30322
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1 Perkins Square
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707 North Broadway
Baltimore, Maryland 21205
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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101 Gregor Mendel Circle
Greenwood, South Carolina 29646
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1653 W. Congress Parkway
Chicago, Illinois 60612
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1935 Medical District Dr
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3901 Beaubien St
Detroit, Michigan 48201
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Durham, North Carolina 27710
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6621 Fannin St
Houston, Texas 77030
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2801 Atlantic Ave
Long Beach, California 90806
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Miller Children's Hospital Miller Children
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4800 Sand Point Way NE
Seattle, Washington 98105
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