Patient Registry of Intrathecal Ziconotide Management(PRIZM)

Patient Registry of Intrathecal Ziconotide Management (PRIZM): An Open-Label, Long Term, Multi-Center, Observational Study of PRIALT® (Ziconotide) Solution, Intrathecal Infusion, in Patients With Severe Chronic Pain

The objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (HRQoL) associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.

Inclusion Criteria:

• Patient is at least 18 years of age at the time of study entry.
• Patient who has severe chronic pain, whom IT therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or IT morphine.
• Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.
• Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.
• Patient has a life expectancy >6 months as determined by the physician.
• Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.
• Patient is able to understand and complete required assessments.

Exclusion Criteria:

• Patient has a known hypersensitivity to PRIALT or any of its formulation components.
• Patient has a pre-existing history of psychosis.
• Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.
• Patient is being initiated with PRIALT in conjunction with other IT agents.
• Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.