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

Piramal

Status and phase

Completed

Phase 3

Conditions

Severe Spasticity

Treatments

Device: SynchroMed® II Programmable Pump

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01520545

CNS-GAB101US

Details and patient eligibility

About

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

Full 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.

Enrollment

153 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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