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

NCT ID: NCT01520545

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-10-31

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.

Conditions

Severe Spasticity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gablofen 3 mg/mL (baclofen Injection)

3 mg/mL Gablofen (baclofen Injection)

Group Type: EXPERIMENTAL

Gablofen® 3 mg/mL (baclofen injection)

Intervention Type: DRUG

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.

SynchroMed® II Programmable Pump

Intervention Type: DEVICE

Intrathecal programmable pump

Interventions

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.

Intervention Type: DRUG

SynchroMed® II Programmable Pump

Intrathecal programmable pump

Intervention Type: DEVICE

Other Intervention Names

baclofen injection

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Piramal Critical Care, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Francisco, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Loma Linda University

Loma Linda, California, United States

Rehabilitation Medicine Department, University of Miami, Miller School of Medicine

Miami, Florida, United States

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Wayne State University, School of Medicine

Dearborn, Michigan, United States

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Vanderbilt University Medical Center, Department of Pediatrics

Nashville, Tennessee, United States

Cook Children's Health Care System

Fort Worth, Texas, United States

TIRR Memorial Hermann

Houston, Texas, United States

University of Utah, Division of PM&R

Salt Lake City, Utah, United States

The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNS-GAB101US

Identifier Type: -

Identifier Source: org_study_id