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Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Rez Farid, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01352611
First received: May 10, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Tactile Defensiveness
Autism Spectrum Disorder
Drug: baclofen, intrathecal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Modified Short Sensory Profile. [ Time Frame: Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen ] [ Designated as safety issue: No ]
    Changes in tactile defensiveness will be documented on the tactile, movement, and visual/auditory sensitivity sub-scales of a Modified Short Sensory Profile.


Secondary Outcome Measures:
  • Clinical Global Impression of Change in Autism Symptoms [ Time Frame: Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen ] [ Designated as safety issue: No ]
    Changes in symptoms of autism spectrum disorder from pre-treatment baseline to post-treatment.


Estimated Enrollment: 5
Study Start Date: September 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lioresal, intrathecal.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352611

Contacts
Contact: Fred Murdock, PhD 573-884-5217 murdockf@health.missouri.edu
Contact: Anne Bonnett, RN 573-884-6119 bonnetta@health.missouri.edu

Locations
United States, Missouri
University Hospital/University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Principal Investigator: Reza S. Farid, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Reza S. Farid, MD University of Missouri-Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: Rez Farid, Associate Professor of Clinical Physical Medicine and Rehabilitation, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01352611     History of Changes
Other Study ID Numbers: 1109397
Study First Received: May 10, 2011
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Tactile Defensiveness
Autistic Disorder

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 23, 2014