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Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome (Harbor-A)

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ClinicalTrials.gov Identifier: NCT01282268
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.

Study Description
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Brief Summary:
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)

Condition or disease Intervention/treatment Phase
Fragile X Syndrome Drug: arbaclofen Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome
Study Start Date : May 2011
Actual Primary Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arbaclofen Drug: arbaclofen
orally disintegrating tablet
Other Name: STX209
Placebo Comparator: Placebo Drug: placebo
orally disintegrating tablet


Outcome Measures
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Primary Outcome Measures :
  1. Aberrant Behavior Checklist - FXS Social Avoidance Subscale [ Time Frame: At 8 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282268


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Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
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Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
More Information
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Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01282268     History of Changes
Other Study ID Numbers: 209FX301
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Seaside Therapeutics, Inc.:
fragile X syndrome
autism spectrum disorder

Additional relevant MeSH terms:
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Syndrome
Fragile X Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System