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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01282268
First received: January 20, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Fragile X Syndrome
Drug: arbaclofen
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seaside Therapeutics, Inc.:

Primary Outcome Measures:
  • Aberrant Behavior Checklist - FXS Social Avoidance Subscale [ Time Frame: At 8 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: May 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arbaclofen Drug: arbaclofen
orally disintegrating tablet
Other Name: STX209
Placebo Comparator: Placebo Drug: placebo
orally disintegrating tablet

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282268

  Show 24 Study Locations
Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01282268     History of Changes
Other Study ID Numbers: 209FX301
Study First Received: January 20, 2011
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Mental Retardation
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

ClinicalTrials.gov processed this record on April 16, 2014