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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00846547
First received: February 17, 2009
Last updated: May 10, 2013
Last verified: May 2013
Results First Received: February 14, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Autism Spectrum Disorders
Intervention: Drug: Arbaclofen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arbaclofen Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period

Participant Flow:   Overall Study
    Arbaclofen  
STARTED     32  
COMPLETED     25  
NOT COMPLETED     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arbaclofen Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period

Baseline Measures
    Arbaclofen  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     32  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.8  ± 3.13  
Gender  
[units: participants]
 
Female     3  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     32  



  Outcome Measures

1.  Primary:   Irritability Subscale of the Aberrant Behavior Checklist, Community Version   [ Time Frame: At 8 weeks during the treatment period ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Paul Wang, Vice President of Clinical and Medical Affairs
Organization: Seaside Therapeutics
phone: 617-374-9009 ext 1015
e-mail: pwang@seasidetherapeutics.com


No publications provided


Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00846547     History of Changes
Other Study ID Numbers: 22003
Study First Received: February 17, 2009
Results First Received: February 14, 2013
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration