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Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT00846547
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : June 14, 2013
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autism Spectrum Disorders
Intervention Drug: Arbaclofen
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arbaclofen
Hide Arm/Group Description Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Period Title: Overall Study
Started 32
Completed 25
Not Completed 7
Arm/Group Title Arbaclofen
Hide Arm/Group Description Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
32
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
11.8  (3.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
3
   9.4%
Male
29
  90.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Irritability Subscale of the Aberrant Behavior Checklist, Community Version
Hide Description The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).
Time Frame At 8 weeks during the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arbaclofen
Hide Arm/Group Description:
Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Overall Number of Participants Analyzed 32
Least Squares Mean (Standard Error)
Unit of Measure: Points on a scale
-8.9  (1.73)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arbaclofen
Hide Arm/Group Description Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
All-Cause Mortality
Arbaclofen
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arbaclofen
Affected / at Risk (%) # Events
Total   1/32 (3.13%)    
Psychiatric disorders   
increased aggression *  1/32 (3.13%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arbaclofen
Affected / at Risk (%) # Events
Total   28/32 (87.50%)    
Gastrointestinal disorders   
diarrhoea *  4/32 (12.50%) 
abdominal pain upper *  2/32 (6.25%) 
vomiting *  2/32 (6.25%) 
General disorders   
fatigue *  5/32 (15.63%) 
Infections and infestations   
nasopharyngitis *  3/32 (9.38%) 
pharyngitis streptococcal *  2/32 (6.25%) 
upper respiratory tract infection *  2/32 (6.25%) 
Metabolism and nutrition disorders   
decreased appetite *  2/32 (6.25%) 
Nervous system disorders   
headache *  3/32 (9.38%) 
dizziness *  2/32 (6.25%) 
Psychiatric disorders   
agitation *  7/32 (21.88%) 
irritability *  7/32 (21.88%) 
psychomotor hyperactivity *  5/32 (15.63%) 
insomnia *  4/32 (12.50%) 
aggression *  3/32 (9.38%) 
disturbance in attention *  3/32 (9.38%) 
self injurious behaviour *  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
cough *  2/32 (6.25%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Seaside Therapeutics agreements with investigators vary; constant is our right to restrict communications regarding trial results prior to public release for ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Dr. Paul Wang, Vice President of Clinical and Medical Affairs
Organization: Seaside Therapeutics
Phone: 617-374-9009 ext 1015
Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00846547     History of Changes
Other Study ID Numbers: 22003
First Submitted: February 17, 2009
First Posted: February 18, 2009
Results First Submitted: February 14, 2013
Results First Posted: June 14, 2013
Last Update Posted: June 14, 2013