Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump

Phase 3

Completed

Interventions: Drug: Gablofen® 3 mg/mL (baclofen injection)
Device: SynchroMed® II Programmable Pump

Brief Summary: Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump

Detailed Description: This is a prospective 36-month Phase IIIb/IV clinical safety trial that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. All patients will be entered after signing an IRB approved informed consent. 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. Patients will be evaluated for clinical complications associated with the use of intrathecal baclofen that are considered signs and symptoms of an inflammatory granuloma, specifically new radicular pain at the level of the catheter tip, and/or spinal cord compression. An MRI scan with and without infusion will be performed (with consent of the patient) to evaluate the potential presence of an inflammatory granuloma if clinical signs exist. Events that may be related to an inflammatory granuloma will be classified as a definite granuloma, possible granuloma, other catheter related problem (confirmed not caused by a granuloma), or other clinical sequelae caused by the underlying disease or other infusion system related event.

Recruitment & Eligibility

Inclusion Criteria

4 years of age or older
Subjects must be clinically diagnosed with sever spasticity and be receiving intrathecal baclofen
Subjects must have a SynchroMed® II Pump already implanted
Current treatment with intrathecal baclofen should be at the 2 mg/mL concentration
Life expectancy greater than or equal to 12 months
Signed written informed consent
Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures

Exclusion Criteria

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
History of any allergic reaction to baclofen
History of inflammatory granulomas with an intrathecal infusion pump
Any previous history of neuroleptic malignant syndrome or malignant hyperthermia
As a result of medical review and physical examination, the Investigator considers the subject unfit for the study

Arm && Interventions

Group	Intervention	Description
Gablofen 3 mg/mL (baclofen Injection)	Gablofen® 3 mg/mL (baclofen injection)	3 mg/mL Gablofen (baclofen Injection)
Gablofen 3 mg/mL (baclofen Injection)	SynchroMed® II Programmable Pump	3 mg/mL Gablofen (baclofen Injection)

Primary Outcome Measures

Name	Time	Method
The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.	36-months	The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.

Secondary Outcome Measures

Name	Time	Method
Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration	36-months	Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration

Locations (13): Wayne State University, School of Medicine
🇺🇸
Dearborn, Michigan, United States
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine
🇺🇸
Miami, Florida, United States
University of Utah, Division of PM&R
🇺🇸
Salt Lake City, Utah, United States
Vanderbilt University Medical Center, Department of Pediatrics
🇺🇸
Nashville, Tennessee, United States
The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation
🇺🇸
Milwaukee, Wisconsin, United States
Cook Children's Health Care System
🇺🇸
Fort Worth, Texas, United States
Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
Loma Linda University
🇺🇸
Loma Linda, California, United States
Rehabilitation Institute of Chicago
🇺🇸
Chicago, Illinois, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Gillette Children's Specialty Healthcare
🇺🇸
Saint Paul, Minnesota, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
TIRR Memorial Hermann
🇺🇸
Houston, Texas, United States