Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

Autism Spectrum Disorder Clinical Trial

Official title:

Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01352611
• Other study ID #: 1109397
• Status: Withdrawn
• Phase: N/A
• First received: May 10, 2011
• Last updated: October 5, 2016
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Drug:
• baclofen, intrathecal
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.

Locations

Country	Name	City	State
United States	University Hospital/University of Missouri Health Care	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical Global Impression of Change in Autism Symptoms	Changes in symptoms of autism spectrum disorder from pre-treatment baseline to post-treatment.	Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen	No

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