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

July 30, 2013 updated by: Seaside Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Autism Research & Resource Center
    • California
      • Los Angeles, California, United States, 90024
        • University of California-Los Angeles Neuropsychiatric Institute
      • Sacramento, California, United States, 95817
        • University of California-Davis, M.I.N.D. Institute
    • Florida
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • Orange City, Florida, United States, 32763
        • Lake Mary Pediatrics
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Institute For Behavioral Medicine
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Institute for Juvenile Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders
    • New York
      • New York, New York, United States, 10029
        • Seaver Autism Center, Mount Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Neurosciences Hospital
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee Medical Group, LeBonheur Children's Hospital
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Kennedy Center
    • Texas
      • Houston, Texas, United States, 77090
        • Red Oaks Psychiatry Associates, P.A.
      • San Antonio, Texas, United States, 78258
        • Road Runner Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
ACTIVE_COMPARATOR: Arbaclofen
Drug: Arbaclofen
Other Names:
  • STX209, R-baclofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aberrant Behavior Checklist-Social Withdrawal Subscale
Time Frame: At 8 weeks of treatment
At 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seaside Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (ESTIMATE)

February 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209AS208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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