NCT01352611|Withdrawn
Study Stopped
No subjects enrolled.
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No subjects enrolled.
Sponsor study identifier
interventional
0
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2011
Actual (reported)May 12, 2011
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 2015
Actual (reported)April 2015
Actual (reported)Modified Short Sensory Profile.
Changes in tactile defensiveness will be documented on the tactile, movement, and visual/auditory sensitivity sub-scales of a Modified Short Sensory Profile.
Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen
Clinical Global Impression of Change in Autism Symptoms
Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen
A single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.
Patients will undergo a standard intrathecal baclofen trial procedure. This procedure consists of a single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.
University Hospital/University of Missouri Health Care
Columbia, Missouri, 65212, United States
Farid, R.S., Nevel, R. and Murdock, F. Effect of Intrathecal Baclofen on Severe Tactile Defensiveness and Symptoms of Autism Spectrum Disorder. Abstract. International Meeting for Autism Research, Philadelphia, PA. May, 2010.
Reza S. Farid, MD
University of Missouri-Columbia
0 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2011
First Posted
May 12, 2011
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
STEPS: Stepped Transition in Education Program for Students With ASD
Contact the study team to confirm eligibility.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
October 6, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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