Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

Withdrawn before enrolling · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.

Key facts

Study ID

NCT01352611

Run by

University of Missouri-Columbia

People needed

0

Starts

2014-09-01

Expected to finish

2015-04-01

Last updated by the study team

2016-10-06

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.