Patient Registry of Intrathecal Ziconotide Management(PRIZM)

Completed

Conditions studied: Patients With Severe Chronic Pain

In brief

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.

Key facts

Study ID

NCT01888120

Run by

Jazz Pharmaceuticals

People needed

93

Starts

2013-07-01

Expected to finish

2017-03-01

Last updated by the study team

2017-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tennessee Valley Pain Consultants — Huntsville, Alabama, United States
• Valley Pain Specialists — Chandler, Arizona, United States
• Desert Pain Institute — Mesa, Arizona, United States
• Valley Pain Specialists — Scottsdale, Arizona, United States
• White River Health System — Batesville, Arkansas, United States
• United Pain Care — Sherwood, Arkansas, United States
• Coastal Pain Research — Carlsbad, California, United States
• Pain Therapy Solutions — Chino, California, United States
• Pain Medicine Associates, Inc. — Fountain Valley, California, United States
• University of California, San Diego — La Jolla, California, United States
• Napa Pain Institute — Napa, California, United States
• Cypress Ambulatory Surgery Center — Santa Maria, California, United States
• Orthopedic Pain Specialists — Santa Monica, California, United States
• Colorado Pain Clinic — Loveland, Colorado, United States
• St. Francis Pain Center — Wilmington, Delaware, United States
• Clearwater Pain Management — Clearwater, Florida, United States
• Florida Pain Institute — Merritt Island, Florida, United States
• AMPM Research Clinic — Miami, Florida, United States
• Kennedy-White Orthopaedic Center — Sarasota, Florida, United States
• JM Clinical Research — South Miami, Florida, United States
• Tallahassee Neurological Clinic — Tallahassee, Florida, United States
• Shepherd Center, Inc — Atlanta, Georgia, United States
• Exodus Pain Clinic — Boise, Idaho, United States
• Thompson and Chou Center for PM&R — Louisville, Kentucky, United States
• Ana Pain Management — Clinton Township, Michigan, United States

Full record on ClinicalTrials.gov

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