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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Seaside Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01706523

First received: October 10, 2012

Last updated: NA

Last verified: October 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 10, 2012

Last Updated Date

October 10, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of STX209 [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Aberrant Behavior Checklist [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]

Open-label assessment of change from baseline on the ABC

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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:

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Autism Spectrum Disorders

Intervention ^ICMJE

Drug: STX209 (arbaclofen)

Long-term, daily, orally-administered STX209

Study Arm (s)

Experimental: STX209

Active treatment with STX209

Intervention: Drug: STX209 (arbaclofen)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

165

Estimated Completion Date

December 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01706523

Other Study ID Numbers ^ICMJE

209AS209

Has Data Monitoring Committee

Yes

Responsible Party

Seaside Therapeutics, Inc.

Study Sponsor ^ICMJE

Seaside Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Paul Wang, M.D.

Seaside Therapeutics, Inc.

Information Provided By

Seaside Therapeutics, Inc.

Verification Date

October 2012

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

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