Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen
Information source: University of Missouri-Columbia
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tactile Defensiveness; Autism Spectrum Disorder
Intervention: baclofen, intrathecal (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: University of Missouri-Columbia Official(s) and/or principal investigator(s): Reza S. Farid, MD, Principal Investigator, Affiliation: University of Missouri-Columbia
Summary
The purpose of this study is to determine if intrathecal administration of baclofen can
reduce symptoms of severe tactile defensiveness and autism spectrum disorder.
Some people with autism spectrum disorder do not like to be touched. This is referred to as
tactile defensiveness. Baclofen is a drug approved for treatment of spasticity in patients
with conditions such as cerebral palsy, spinal cord injury and traumatic brain injury.
Intrathecal means that baclofen is administered by injection into the spinal canal. In this
study, each patient will undergo a trial administration of intrathecal baclofen and the
effect of intrathecal baclofen on symptoms of tactile defensiveness and autism spectrum
disorder will be evaluated.
Each patient will have three visits in connection with the study. First, there will be a
screening visit in which the investigators determine if the patient is eligible to
participate in the study. To participate, each patient must have autism spectrum disorder,
severe tactile defensiveness, and meet other listed criteria. At the second visit, each
patient will undergo the intrathecal baclofen trial procedure. The procedure used is the
standard procedure to determine if intrathecal baclofen is effective for treatment of
spasticity. In this study however, instead of evaluating the effect of intrathecal baclofen
on spasticity, the investigators will evaluate the effect of intrathecal baclofen on
symptoms of tactile defensiveness and autism spectrum disorder. The trial procedure and
evaluation will require about one day. At the third visit, the follow up visit, the
investigators will evaluate and discuss the patient's response to the treatment.
Clinical Details
Official title: Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Modified Short Sensory Profile.
Secondary outcome: Clinical Global Impression of Change in Autism Symptoms
Eligibility
Minimum age: 10 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Diagnosis of autism prior to study entry
2. Exhibits these specific symptoms of autism:
- Tactile Defensiveness
- Increased sensitivity to sensory stimulation
3. Patients must be scored as "Always" for "Reacts emotionally or aggressively to touch"
on a modified Short Sensory Profile Questionnaire. Additionally, patients must score
"Always" or "Frequently" in the other categories of a modified Short Sensory Profile
Questionnaire
Exclusion Criteria:
1. Allergy to baclofen or compounds with similar structure
2. Unable to be evaluated by the chosen efficacy measures
3. Any condition that in the opinion of the principal investigator will place the
patient at increased risk of adverse events or preclude completion of the study
4. Concomitant use of any medication that in the opinion of the principal investigator
is contraindicated with intrathecal baclofen administration
5. Females of child-bearing potential who have a positive urine pregnancy test at visit
2
Locations and Contacts
University Hospital/University of Missouri Health Care, Columbia, Missouri 65212, United States
Additional Information
Link to Citation
Related publications: 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.
Starting date: September 2014
Last updated: April 28, 2015
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