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

Information source: Mallinckrodt
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Spasticity

Intervention: Gablofen® 3 mg/mL (baclofen injection) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Mallinckrodt

Official(s) and/or principal investigator(s):
Gerard Francisco, MD, Principal Investigator, Affiliation: University of Texas

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.

Secondary outcome: Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration

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.

Eligibility

Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States

Loma Linda University, Loma Linda, California 92354, United States

Rehabilitation Medicine Department, University of Miami, Miller School of Medicine, Miami, Florida 33136, United States

Rehabilitation Institute of Chicago, Chicago, Illinois 60611, United States

Wayne State University, School of Medicine, Dearborn, Michigan 48124, United States

Gillette Children's Specialty Healthcare, St. Paul, Minnesota 55101, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

The Ohio State University, Columbus, Ohio 43221, United States

Vanderbilt University Medical Center, Department of Pediatrics, Nashville, Tennessee 37232, United States

Cook Children's Health Care System, Fort Worth, Texas 76104, United States

TIRR Memorial Hermann, Houston, Texas 77030, United States

University of Utah, Division of PM&R, Salt Lake City, Utah 84132, United States

The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: January 2013
Last updated: June 5, 2015

Page last updated: August 20, 2015

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