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

Primary Purpose

Autism Spectrum Disorders

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
STX209 (arbaclofen)
Sponsored by
Seaside Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Autism Spectrum Disorders, Autism, Asperger, Pervasive Developmental Disorder - Not otherwise specified

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Autism Research & Resource Center
  • University of California-Los Angeles Neuropsychiatric Institute
  • UCDavis M.I.N.D Insitute
  • Pharmax Research Clinic
  • Lake Mary Pediatrics
  • Institute for Behavioral Medicine
  • Institute for Juvenile Research
  • Riley Hospital for Children
  • Kennedy Krieger Institute
  • Boston Children's Hospital
  • University of Massachusetts
  • University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders
  • Seaver Autism Center, Mount Sinai Medical Center
  • NYS Institute for Basic Research in Developmental Disabilities
  • UNC Chapel Hill Department of Psychiatry
  • Akron Children's Hospital
  • Cutting Edge Research
  • Summit Research Network
  • Suburban Research Associates
  • Children's Hospital of Philadelphia
  • University of Tennessee Medical Group, LeBonheur Children's Hospital
  • Vanderbilt Kennedy Center
  • Red Oaks Psychiatry Associates, P.A.
  • Road Runner Research
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STX209

Arm Description

Active treatment with STX209

Outcomes

Primary Outcome Measures

Safety and tolerability of STX209
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments

Secondary Outcome Measures

Aberrant Behavior Checklist
Open-label assessment of change from baseline on the ABC

Full Information

First Posted
October 10, 2012
Last Updated
July 30, 2013
Sponsor
Seaside Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01706523
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seaside Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Autism Spectrum Disorders, Autism, Asperger, Pervasive Developmental Disorder - Not otherwise specified

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STX209
Arm Type
Experimental
Arm Description
Active treatment with STX209
Intervention Type
Drug
Intervention Name(s)
STX209 (arbaclofen)
Intervention Description
Long-term, daily, orally-administered STX209
Primary Outcome Measure Information:
Title
Safety and tolerability of STX209
Description
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
Time Frame
100 weeks
Secondary Outcome Measure Information:
Title
Aberrant Behavior Checklist
Description
Open-label assessment of change from baseline on the ABC
Time Frame
100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Wang, M.D.
Organizational Affiliation
Seaside Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Autism Research & Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California-Los Angeles Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCDavis M.I.N.D Insitute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Pharmax Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Lake Mary Pediatrics
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Institute for Behavioral Medicine
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Institute for Juvenile Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
Seaver Autism Center, Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NYS Institute for Basic Research in Developmental Disabilities
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
UNC Chapel Hill Department of Psychiatry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cutting Edge Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Tennessee Medical Group, LeBonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt Kennedy Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Red Oaks Psychiatry Associates, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Road Runner Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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

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