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Patient Registry of Intrathecal Ziconotide Management(PRIZM)

CompletedNCT01888120
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Conditions
  • Patients With Severe Chronic Pain
Interventions
Sponsor
Jazz Pharmaceuticals
Start date
2013-07
Primary completion
2017-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
43

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01888120