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

• ClinicalTrials.gov Identifier: NCT01064973
• Recruitment Status: Terminated
• First Posted: February 9, 2010
• Last Update Posted: December 20, 2012
• Sponsor: Seaside Therapeutics, Inc.
• Information provided by (Responsible Party): Seaside Therapeutics, Inc.

Tracking Information

• First Submitted Date: February 5, 2010
• First Posted Date: February 9, 2010
• Last Update Posted Date: December 20, 2012
• Study Start Date: February 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 5, 2010): Irritability subscale of the Aberrant Behavior Checklist [ Time Frame: every 2 to 3 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders
• Official Title: An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Autism Spectrum Disorders
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Autism Spectrum Disorders

Intervention

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

Study Arms

Experimental: STX209

STX209 (arbaclofen)

Intervention: Drug: arbaclofen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 19, 2012): 32
• Original Estimated Enrollment (submitted: February 5, 2010): 30
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01064973
• Other Study ID Numbers: 22007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seaside Therapeutics, Inc.
• Original Responsible Party: Randall Carpenter, MD, CEO and President, Seaside Therapeutics
• Current Study Sponsor: Seaside Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Seaside Therapeutics, Inc.
• Verification Date: December 2012