Patient Registry of Intrathecal Ziconotide Management(PRIZM)

Jazz Pharmaceuticals

Status: Completed

Conditions: Patients With Severe Chronic Pain

Treatments: Drug: Ziconotide

Study type: Observational

Funder types: Industry

Identifiers

NCT01888120

13-001

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

93 participants in 1 patient group

Severe Chronic Pain

Treatment:

Drug: Ziconotide