153
Participants
Start Date
December 31, 2012
Primary Completion Date
August 31, 2016
Study Completion Date
October 31, 2016
Gablofen® 3 mg/mL (baclofen injection)
This is a prospective twelve-month Phase IIIb clinical safety trial followed by a 2-year, Phase IV study that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated.
SynchroMed® II Programmable Pump
Intrathecal programmable pump
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine, Miami
Vanderbilt University Medical Center, Department of Pediatrics, Nashville
The Ohio State University, Columbus
Cleveland Clinic Foundation, Cleveland
Wayne State University, School of Medicine, Dearborn
The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation, Milwaukee
Gillette Children's Specialty Healthcare, Saint Paul
Rehabilitation Institute of Chicago, Chicago
Arkansas Children's Hospital, Little Rock
Cook Children's Health Care System, Fort Worth
TIRR Memorial Hermann, Houston
University of Utah, Division of PM&R, Salt Lake City
Loma Linda University, Loma Linda
Piramal Critical Care, Ltd.
INDUSTRY