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

Primary Purpose

Autism Spectrum Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Arbaclofen

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Autism, Autism Spectrum Disorders, irritability, aberrant behavior

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Southwest Autism Research & Resource Center
University of California-Los Angeles Neuropsychiatric Institute
Yale Child Study Center
Riley Hospital for Children
University of North Carolina Neurosciences Hospital
Vanderbilt Kennedy Center
Red Oaks Psychiatry Associates, PA
Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arbaclofen

Arm Description

Outcomes

Primary Outcome Measures

Irritability Subscale of the Aberrant Behavior Checklist, Community Version

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00846547

First Posted

February 17, 2009

Last Updated

May 10, 2013

Sponsor

Seaside Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00846547

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seaside Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorders

Keywords

Autism, Autism Spectrum Disorders, irritability, aberrant behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arbaclofen

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Arbaclofen

Other Intervention Name(s)

STX209

Intervention Description

variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period

Primary Outcome Measure Information:

Title

Irritability Subscale of the Aberrant Behavior Checklist, Community Version

Description

Time Frame

At 8 weeks during the treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: