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

Severe Spasticity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520545
• Other study ID #: CNS-GAB101US
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: October 2016

Study information

• Verified date: April 2019
• Source: Piramal Critical Care, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

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

Related Conditions & MeSH terms

• Severe Spasticity

Intervention

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.

Device:
• SynchroMed® II Programmable Pump
Intrathecal programmable pump

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Wayne State University, School of Medicine	Dearborn	Michigan
United States	Cook Children's Health Care System	Fort Worth	Texas
United States	TIRR Memorial Hermann	Houston	Texas
United States	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	The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center, Department of Pediatrics	Nashville	Tennessee
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	University of Utah, Division of PM&R	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Critical Care, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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