Status:
COMPLETED
Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
Lead Sponsor:
Seaside Therapeutics, Inc.
Conditions:
Autism Spectrum Disorders
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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 irritabili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00846547
Start Date
February 1 2009
End Date
September 1 2010
Last Update
June 14 2013
Active Locations (8)
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1
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
2
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States, 90024
3
Yale Child Study Center
New Haven, Connecticut, United States, 06520
4
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202