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Autism Spectrum Disorder | Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

Autism Spectrum Disorder research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Autism Spectrum Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:baclofen, intrathecalPatients 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Withdrawn

Start Date: September 2014

Completed Date: April 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Modified Short Sensory Profile.

Secondary Outcome: Clinical Global Impression of Change in Autism Symptoms

Study sponsors, principal investigator, and references

Principal Investigator: Reza S. Farid, MD

Lead Sponsor: University of Missouri-Columbia

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01352611

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.

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