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 |
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
We found this trial at
28
sites
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
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Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Columbia, Missouri 65211
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Miller Children's Hospital Miller Children
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Staten Island, New York 10314
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