Patient Registry of Intrathecal Ziconotide Management(PRIZM)

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals
• Treatments: omega-Conotoxins; Ziconotide

Criteria

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.