Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

October 5, 2016 updated by: University of Missouri-Columbia
The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University Hospital/University of Missouri Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: baclofen, intrathecal
A single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.
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.
Other Names:
  • Lioresal, intrathecal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Short Sensory Profile.
Time Frame: Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Change in Autism Symptoms
Time Frame: Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Reza S. Farid, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (ESTIMATE)

May 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1109397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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