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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mallinckrodt Identifier:
First received: January 23, 2012
Last updated: October 29, 2015
Last verified: October 2015
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump

Condition Intervention Phase
Severe Spasticity
Drug: Gablofen® 3 mg/mL (baclofen injection)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System

Resource links provided by NLM:

Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration. [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gablofen 3 mg/mL (baclofen Injection)
3 mg/mL Gablofen (baclofen Injection)
Drug: 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.
Other Name: baclofen injection

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.

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01520545

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
United States, Florida
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University, School of Medicine
Dearborn, Michigan, United States, 48124
United States, Minnesota
Gillette Children's Specialty Healthcare
St. Paul, Minnesota, United States, 55101
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43221
United States, Tennessee
Vanderbilt University Medical Center, Department of Pediatrics
Nashville, Tennessee, United States, 37232
United States, Texas
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
TIRR Memorial Hermann
Houston, Texas, United States, 77030
United States, Utah
University of Utah, Division of PM&R
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Principal Investigator: Gerard Francisco, MD University of Texas
  More Information

No publications provided

Responsible Party: Mallinckrodt Identifier: NCT01520545     History of Changes
Other Study ID Numbers: CNS-GAB101US, CNS-GAB101US
Study First Received: January 23, 2012
Last Updated: October 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
baclofen injection processed this record on November 25, 2015