Keywords: ITB Pump , Muscle Spasticity
IRB Number: 00060566
Specialty: Physical Medicine and Rehabilitation, Physical Medicine and Rehabilitation, Physical Medicine and Rehabilitation
Sub Specialties: Stroke , Pediatric Spasticity Management, Traumatic Brain Injury
• The primary objective of this safety and post-approval surveillance study is to obtain data on the rate of inflammatory granulomas in patients given Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.
• To evaluate the overall safety data on 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration. From the sponsor: The safety data will be presented as a summary statistic. It will be inclusive of the ITT and safety population on all subjects who were deemed eligible, signed an informed consent form and were treated with 3mg/mL Gablofen. There will also be the Per Protocol Population who were deemed eligible, signed the informed consent form and were clinically evaluated for inflammatory granuloma, received therapy for 12 months and had not major deviations.
Principal Investigator: Steven Edgley
Department: Physical Medicine & Rehab