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
Recruitment status was Active, not recruiting
Sponsor:
Seaside Therapeutics, Inc.
Information provided by:
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00846547
First received: February 17, 2009
Last updated: February 22, 2010
Last verified: February 2010
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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 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:
- 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 September 26, 2012
