Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders - NCT00846547-06520 (Clinical Trial 272801)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy272801.aspx
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New Haven |
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State:
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CT |
| Zip Code: |
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06520 |
| Conditions: |
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Autism Spectrum Disorders |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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