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An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01064973
Recruitment Status : Terminated (all active subjects were rolled into study 209AS209/NCT01706523)
First Posted : February 9, 2010
Last Update Posted : December 20, 2012
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.

February 5, 2010
February 9, 2010
December 20, 2012
February 2010
December 2012   (Final data collection date for primary outcome measure)
Irritability subscale of the Aberrant Behavior Checklist [ Time Frame: every 2 to 3 months ]
Same as current
Complete list of historical versions of study NCT01064973 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders
An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Autism Spectrum Disorders
Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Autism Spectrum Disorders
Drug: arbaclofen
A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the oral OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID
Other Name: R-baclofen, STX209, arbaclofen
Experimental: STX209
STX209 (arbaclofen)
Intervention: Drug: arbaclofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
30
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator

Exclusion Criteria:

  • Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
  • The occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01064973
22007
No
Not Provided
Not Provided
Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
Not Provided
Not Provided
Seaside Therapeutics, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP