View Clinical Trial (Medical Research Study)
Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen
| City: |
|
Columbia |
| State: |
|
Missouri |
| Zip Code: |
|
65212 |
| Conditions: |
|
Tactile Defensiveness - Autism Spectrum Disorder |
| 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.
|
| Study Summary: |
|
|
| 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
|
| NCT ID: |
|
NCT01352611 |
| Primary Contact: |
|
Principal Investigator
Reza S. Farid, MD
University of Missouri-Columbia
Fred Murdock, PhD
Phone: 573-884-5217
Email: murdockf@health.missouri.edu
|
| Backup Contact: |
|
Email: bonnetta@health.missouri.edu
Anne Bonnett, RN
Phone: 573-884-6119
|
| Location Contact: |
|
Columbia, Missouri 65212
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|