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Trial record 4 of 7 for:    stx209 and fragile x syndrome

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01325220
First received: March 28, 2011
Last updated: July 30, 2013
Last verified: July 2013

March 28, 2011
July 30, 2013
June 2011
June 2013   (final data collection date for primary outcome measure)
Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale [ Time Frame: at 8 weeks of treatment ] [ Designated as safety issue: No ]
This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal
Same as current
Complete list of historical versions of study NCT01325220 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fragile X Syndrome
  • Drug: arbaclofen
    5 mg bid
    Other Name: R-baclofen, STX209
  • Drug: arbaclofen
    10 mg bid
    Other Name: R-baclofen, STX209
  • Drug: arbaclofen
    10 mg tid
    Other Name: R-baclofen, STX209
  • Drug: Placebo
    tid
  • Active Comparator: STX209 5 mg BID
    Intervention: Drug: arbaclofen
  • Active Comparator: STX209 10 mg BID
    Intervention: Drug: arbaclofen
  • Active Comparator: STX209 10 mg TID
    Intervention: Drug: arbaclofen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01325220
209FX302
Yes
Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
Not Provided
Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP