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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01288716
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: Arbaclofen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
Placebo Comparator: Placebo
Active Comparator: Arbaclofen Drug: Arbaclofen
Other Name: STX209, R-baclofen




Primary Outcome Measures :
  1. Aberrant Behavior Checklist-Social Withdrawal Subscale [ Time Frame: At 8 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288716


Locations
Show Show 24 study locations
Sponsors and Collaborators
Seaside Therapeutics, Inc.
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Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01288716    
Other Study ID Numbers: 209AS208
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by Seaside Therapeutics, Inc.:
ASD
Autism
Asperger Syndrome
Additional relevant MeSH terms:
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Child Development Disorders, Pervasive
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Mental Disorders
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action