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Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00846547
First received: February 17, 2009
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.


Condition Intervention Phase
Autism Spectrum Disorders
Drug: Arbaclofen
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Irritability Subscale of the Aberrant Behavior Checklist, Community Version [ Time Frame: At 8 weeks during the treatment period ] [ Designated as safety issue: No ]
    The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).


Enrollment: 32
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arbaclofen Drug: Arbaclofen
variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Other Name: STX209

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects 6 to 17 years of age, inclusive.
  • Diagnosis of Autistic spectrum disorders
  • Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
  • An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
  • 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 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
  • Exclusion Criteria:
  • Subjects with known genetic disorders associated with PDD such as fragile X syndrome.
  • Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
  • Subjects with any medical condition, including alcohol and drug abuse that 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 currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
  • Subjects currently treated with vigabatrin or tiagabine.
  • Subjects taking another investigational drug currently or within the last 30 days.
  • Subjects who have a history of hypersensitivity to racemic baclofen.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846547

Locations
United States, Arizona
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
United States, California
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States, 90024
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06520
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, North Carolina
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States, 27514
United States, Tennessee
Vanderbilt Kennedy Center
Nashville, Tennessee, United States, 37203
United States, Texas
Red Oaks Psychiatry Associates, PA
Houston, Texas, United States, 77090
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
Principal Investigator: Lawrence Scahill, PhD Yale University
Principal Investigator: Craig Erikson, MD Riley Hospital for Children
Principal Investigator: Bryan King, MD, PhD Seattle Children's Hospital
Principal Investigator: James McCracken, MD University of California, Los Angeles
Principal Investigator: Linmarie Sikich, MD University of North Carolina Neurosciences Hospital
Principal Investigator: Jeremy Veenstra-VanderWeele, MD Vanderbilt Kennedy Center
Principal Investigator: Lawrence Ginsberg, MD Red Oaks Psychiatry Associates, PA
Principal Investigator: Raun Melmed, MD Southwest Autism Research & Resource Center
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00846547     History of Changes
Other Study ID Numbers: 22003
Study First Received: February 17, 2009
Results First Received: February 14, 2013
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seaside Therapeutics, Inc.:
Autism
Autism Spectrum Disorders
irritability
aberrant behavior

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

ClinicalTrials.gov processed this record on November 27, 2014