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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Seaside Therapeutics, Inc.. Recruitment status was Active, not recruiting

First Received on February 17, 2009. Last Updated on February 22, 2010 History of Changes

Sponsor:	Seaside Therapeutics, Inc.
Information provided by:	Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00846547

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 (STX209)	Phase II

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:

MedlinePlus related topics: Autism

U.S. FDA Resources

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

Primary Outcome Measures:

Adverse events [ Time Frame: During the course of the study and for 30 days after the end of the study ] [ Designated as safety issue: Yes ]
Irritability Subscale of the Aberrant Behavior Checklist, Community Version [ Time Frame: At 2, 4, 6, and 8 weeks during the treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arbaclofen	Drug: Arbaclofen (STX209) 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

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:	Study Director, Seaside Therapeutics, LLC
ClinicalTrials.gov Identifier:	NCT00846547 History of Changes
Other Study ID Numbers:	22003
Study First Received:	February 17, 2009
Last Updated:	February 22, 2010
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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012