DRUG
Patient Registry of Intrathecal Ziconotide Management(PRIZM)
Status
Completed
Phase
Not applicable
Enrollment
93
Locations
43
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 27, 2013
Study start
Jul 2013
Primary completion
Jan 2017
Study completion
Mar 2017
Results posted
Not reported
Registry updated
Mar 16, 2017
Outcomes
What the study measures.
Primary outcomes
The effectiveness of PRIALT therapy for the management of severe chronic pain as evidenced by change in patient-reported pain intensity from baseline to 12 weeks after enrollment
Time frame · 12 Weeks
Secondary outcomes
Evaluate the following from the patient's perspective via patient reported outcomes (PROs)
Time frame · From week 12, every 3 months up to month 18
Evaluate the patient's global impression of change (PGIC) with PRIALT treatment
Time frame · From week 12, every 3 months up to month 18
Evaluate changes in concomitant pain medication use
Time frame · From week 12, every 3 months up to month 18
Evaluate long-term safety and tolerability data, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame · From week 12, every 3 months up to month 18
The use of PRIALT in current clinical practice including dose at initiation, titration speed, effective dose, duration of treatment effect, use of other pain medications, etc.
Time frame · From week 12, every 3 months up to month 18
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
43 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
PMID 32472137 ↗McDowell GC, Saulino MF, Wallace M, Grigsby EJ, Rauck RL, Kim P, Vanhove GF, Ryan R, Huang IZ, Deer T. Effectiveness and Safety of Intrathecal Ziconotide: Final Results of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Med. 2020 Nov 1;21(11):2925-2938. doi: 10.1093/pm/pnaa115.PMID 28449352 ↗Deer T, Rauck RL, Kim P, Saulino MF, Wallace M, Grigsby EJ, Huang IZ, Mori F, Vanhove GF, McDowell GC 2nd. Effectiveness and Safety of Intrathecal Ziconotide: Interim Analysis of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Pract. 2018 Feb;18(2):230-238. doi: 10.1111/papr.12599. Epub 2017 Jul 14.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.