Clinical trial NCT01520545: Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Spasticity
Keywords: Gablofen
baclofen injection
Lead sponsor: Piramal Critical Care, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 153
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.
timeFrame: 36-months
Secondary outcomes:
measure: Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration
timeFrame: 36-months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Miami
country: United States
facility: Rehabilitation Medicine Department, University of Miami, Miller School of Medicine
state: Florida
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Dearborn
country: United States
facility: Wayne State University, School of Medicine
state: Michigan
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Pediatrics
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's Health Care System
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Division of PM&R
state: Utah
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation
state: Wisconsin
Study officials:
affiliation: University of Texas
name: Gerard Francisco, MD
role: PRINCIPAL_INVESTIGATOR
References: