Accession Number:

AD1005804

Title:

A Double-Blind, Randomized Study of Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT-A) versus Oral Oxybutynin in SCI Patients with NDO (11-09-10-04)

Descriptive Note:

Technical Report,30 Sep 2014,29 Sep 2015

Corporate Author:

Baylor College of Medicine Houston United States

Personal Author(s):

Report Date:

2015-10-01

Pagination or Media Count:

157.0

Abstract:

No subjects have been treated as yet. Recruitment at Michael E. DeBakey VAMC has been difficult due to eligibility criteria.Dr. Smith plans to open patient recruitment to a new site with a large spinal cord injury population, The Institute of Rehabilitation and Research TIRR. The BCM IRB initial approval of the addition of the TIRR Memorial Hermann site has been approved. The application to the Memorial Hermann Office of Research has been submitted and approval is awaiting final budget agreement. Once the study has been approved by Memorial Hermann, the HPRO will be notified. Recruitment will begin after HPRO approval is received.

Subject Categories:

Distribution Statement:

APPROVED FOR PUBLIC RELEASE