Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

NCT01352611 | Withdrawn

• 1 other identifier: 1109397
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Tactile Defensiveness; Autistic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical Global Impression of Change in Autism Symptoms

  Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen

Study Arms (1)

baclofen, intrathecal

EXPERIMENTAL

A single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.

Drug: baclofen, intrathecal

Interventions

baclofen, intrathecal DRUG

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.

Also known as: Lioresal, intrathecal.

baclofen, intrathecal

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of autism prior to study entry
• Exhibits these specific symptoms of autism:
• Tactile Defensiveness
• Increased sensitivity to sensory stimulation
• 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

You may not qualify if:

• Allergy to baclofen or compounds with similar structure
• Unable to be evaluated by the chosen efficacy measures
• 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
• Concomitant use of any medication that in the opinion of the principal investigator is contraindicated with intrathecal baclofen administration
• Females of child-bearing potential who have a positive urine pregnancy test at visit 2

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital/University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Related 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.

  BACKGROUND

Related Links

• Link to Citation

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Reza S. Farid, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 12, 2011
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)