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

Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System

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

Study Overview

• Status: Completed
• Conditions: Severe Spasticity
• Intervention / Treatment: Drug: Gablofen® 3 mg/mL (baclofen injection); Device: SynchroMed® II 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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: baclofen injection; Device: SynchroMed® II Programmable Pump; Intrathecal programmable pump

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration	Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration	36-months

Collaborators and Investigators

• Sponsor: Piramal Critical Care, Ltd.
• Investigators: Principal Investigator: Gerard Francisco, MD, University of Texas

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Gablofen; baclofen injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: CNS-GAB101US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No