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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Status: Withdrawn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

Page last updated: August 20, 2015

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