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

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.

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