Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

• ClinicalTrials.gov Identifier: NCT01706523
• Recruitment Status: Terminated
• First Posted: October 15, 2012
• Last Update Posted: July 31, 2013
• Sponsor: Seaside Therapeutics, Inc.
• Information provided by (Responsible Party): Seaside Therapeutics, Inc.

Tracking Information

• First Submitted Date: October 10, 2012
• First Posted Date: October 15, 2012
• Last Update Posted Date: July 31, 2013
• Study Start Date: November 2011
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2012)

Safety and tolerability of STX209 [ Time Frame: 100 weeks ]

Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 10, 2012)

Aberrant Behavior Checklist [ Time Frame: 100 weeks ]

Open-label assessment of change from baseline on the ABC

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
• Official Title: An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
• Brief Summary: This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

Detailed Description

This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.

Protocol 209AS208, "A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects with Autism Spectrum Disorders."

Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."

This open-label extension will provide data on the following:

1. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
2. Provide supporting pharmacokinetic analyses
3. Assess long term efficacy on social behaviors in subjects with ASD.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Autism Spectrum Disorders

Intervention

Drug: STX209 (arbaclofen)

Long-term, daily, orally-administered STX209

Study Arms

Experimental: STX209

Active treatment with STX209

Intervention: Drug: STX209 (arbaclofen)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Estimated Enrollment (submitted: October 10, 2012): 165
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2013
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
• Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
• Treatment with no more than 2 psychoactive medications
• Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
• For female subjects, negative pregnancy test

Exclusion Criteria:

• Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
• Current use of illicit drugs or alcohol abuse.
• Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
• Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 21 Years (Child, Adult)
• 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: NCT01706523
• Other Study ID Numbers: 209AS209
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seaside Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Seaside Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Paul Wang, M.D.; Seaside Therapeutics, Inc.

• PRS Account: Seaside Therapeutics, Inc.
• Verification Date: July 2013