Text Size

Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01288716
First received: January 31, 2011
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders


Condition Intervention Phase
Autism Spectrum Disorders
 Drug: Arbaclofen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 Withdrawal in Subjects With Autism Spectrum Disorders

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

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

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

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Arbaclofen
orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid
Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 10 mg dose Drug: Arbaclofen
orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid
Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 20 mg dose Drug: Arbaclofen
orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid
Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 30 mg dose Drug: Arbaclofen
orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid
Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 45 mg dose Drug: Arbaclofen
orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid
Other Name: STX209, R-baclofen

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorders (ASD)
  • 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: NCT01288716

  Show 24 Study Locations
Sponsors and Collaborators
Seaside Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Randall Carpenter, MD, CEO, Seaside Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01288716     History of Changes
Other Study ID Numbers: 209AS208
Study First Received: January 31, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Seaside Therapeutics, Inc.:
ASD
Autism
Asperger Syndrome

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2012