Gablofen 3mg/mL


Status: Completed
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

Brief Summary


Primary objective:

• 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.

Secondary objectives:

• 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
Co Investigator:

Contact Information

Name:Jonna Winger
Phone: 801-581-5328

Inclusion Criteria


1. 4 years of age or older

2. Subjects must be clinically diagnosed with severe spasticity and be receiving intrathecal baclofen

3. Subjects must have a SynchroMed® II Pump already implanted

4. Current treatment with intrathecal baclofen should be at the 2 mg/mL concentration

5. Life expectancy ≥ 12 months

6. Signed written informed consent

7. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures


Exclusion Criteria


1. History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which is allowed

2. History of any allergic reaction to baclofen

3. History of inflammatory granulomas with an intrathecal infusion pump

4. Any previous history of neuroleptic malignant syndrome or malignant hyperthermia

5. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study