Patient Registry of Intrathecal Ziconotide Management(PRIZM) (PRIZM)

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

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 Overview

• Status: Completed
• Conditions: Patients With Severe Chronic Pain
• Intervention / Treatment: Drug: Ziconotide

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Tennessee Valley Pain Consultants
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Valley Pain Specialists
    • Mesa, Arizona, United States, 85206
      • Desert Pain Institute
    • Scottsdale, Arizona, United States, 85006
      • Valley Pain Specialists
  • Arkansas
    • Batesville, Arkansas, United States, 72501
      • White River Health System
    • Sherwood, Arkansas, United States, 72120
      • United Pain Care
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Pain Research
    • Chino, California, United States, 91710
      • Pain Therapy Solutions
    • Fountain Valley, California, United States, 92708
      • Pain Medicine Associates, Inc.
    • La Jolla, California, United States, 92037
      • University of California, San Diego
    • Napa, California, United States, 94558
      • Napa Pain Institute
    • Santa Maria, California, United States, 93454
      • Cypress Ambulatory Surgery Center
    • Santa Monica, California, United States, 90403
      • Orthopedic Pain Specialists
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Colorado Pain Clinic
  • Delaware
    • Wilmington, Delaware, United States, 19713
      • St. Francis Pain Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Pain Management
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
    • Miami, Florida, United States, 33169
      • AMPM Research Clinic
    • Sarasota, Florida, United States, 34232
      • Kennedy-White Orthopaedic Center
    • South Miami, Florida, United States, 33143
      • JM Clinical Research
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center, Inc
  • Idaho
    • Boise, Idaho, United States, 83713
      • Exodus Pain Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40204
      • Thompson and Chou Center for PM&R
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Ana Pain Management
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Kozmary Center for Pain Management
  • New York
    • Utica, New York, United States, 13502
      • Spinal & Skeletal Pain Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research/Carolinas Pain Institute
  • Ohio
    • Columbus, Ohio, United States, 43219
      • Integrated Pain Solutions
    • Cuyahoga Falls, Ohio, United States, 44223
      • Summa Health System Western Reserve Hospital
  • Oregon
    • Ashland, Oregon, United States, 97520
      • Ashland Neurosurgery
    • Ashland, Oregon, United States, 97520
      • Cedar Sinai Medical Center
    • Portland, Oregon, United States, 97209
      • OAG Interventional Pain Consultants
    • Portland, Oregon, United States, 97209
      • Oregon Anesthesiologist Group Interventional Pain Consultants
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Einstein Physician Practice, Inc.
    • Greensburg, Pennsylvania, United States, 15601
      • DNA Advanced Pain Treatment Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Houston Pain Associates
    • Webster, Texas, United States, 77598
      • Space City Pain Specialists LLP
  • Virginia
    • Stafford, Virginia, United States, 22554
      • Advanced Spine and Pain
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Center for Pain Relief
    • Huntington, West Virginia, United States, 25702
      • The Center of Pain Relief Tri-State
  • Wisconsin
    • Madison, Wisconsin, United States, 53718
      • Anesthesia & Chronic Pain / University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 140 patients will be enrolled at approximatley 50 sites in the United States.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe Chronic Pain	Drug: Ziconotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the following from the patient's perspective via patient reported outcomes (PROs)	From week 12, every 3 months up to month 18
Evaluate the patient's global impression of change (PGIC) with PRIALT treatment	From week 12, every 3 months up to month 18
Evaluate changes in concomitant pain medication use	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)	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.	From week 12, every 3 months up to month 18

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals
• Investigators: Study Director: I-Zu Huang, MD, Jazz Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Ziconotide
• Other Study ID Numbers: 13-001