Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

• Status: Withdrawn
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Baclofen

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