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Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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 ASD, Autism, Asperger Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorders (ASD)
  • Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
  • Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
  • If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

Exclusion Criteria:

  • Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
  • Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
  • Subjects who have taken another investigational drug within the last 30 days.
  • Subjects who are not able to take oral medications

Sites / Locations

  • Southwest Autism Research & Resource Center
  • University of California-Los Angeles Neuropsychiatric Institute
  • University of California-Davis, M.I.N.D. Institute
  • 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 & Neurodevelpmental Disorders
  • Seaver Autism Center, Mount Sinai Medical Center
  • University of North Carolina Neurosciences Hospital
  • 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 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Arbaclofen

Arm Description

Outcomes

Primary Outcome Measures

Aberrant Behavior Checklist-Social Withdrawal Subscale

Secondary Outcome Measures

Full Information

First Posted
January 31, 2011
Last Updated
July 30, 2013
Sponsor
Seaside Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01288716
Brief Title
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)

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
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
ASD, Autism, Asperger Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Arbaclofen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Arbaclofen
Other Intervention Name(s)
STX209, R-baclofen
Primary Outcome Measure Information:
Title
Aberrant Behavior Checklist-Social Withdrawal Subscale
Time Frame
At 8 weeks of treatment

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: Diagnosis of Autism Spectrum Disorders (ASD) Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening. Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening Exclusion Criteria: Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. Subjects who have taken another investigational drug within the last 30 days. Subjects who are not able to take oral medications
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
University of California-Davis, M.I.N.D. Institute
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 & Neurodevelpmental 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
University of North Carolina Neurosciences Hospital
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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Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

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