Patient Registry of Intrathecal Ziconotide Management(PRIZM)

NCT01888120 | Completed

• 1 other identifier: 13-001
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 43

Brief Summary

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.

Conditions

Patients With Severe Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Severe Chronic Pain

Drug: Ziconotide

Interventions

Ziconotide DRUG

Severe Chronic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (43)

Tennessee Valley Pain Consultants

Huntsville, Alabama, 35801, United States

Location

Valley Pain Specialists

Chandler, Arizona, 85224, United States

Location

Desert Pain Institute

Mesa, Arizona, 85206, United States

Location

Valley Pain Specialists

Scottsdale, Arizona, 85006, United States

Location

White River Health System

Batesville, Arkansas, 72501, United States

Location

United Pain Care

Sherwood, Arkansas, 72120, United States

Location

Coastal Pain Research

Carlsbad, California, 92009, United States

Location

Pain Therapy Solutions

Chino, California, 91710, United States

Location

Pain Medicine Associates, Inc.

Fountain Valley, California, 92708, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Napa Pain Institute

Napa, California, 94558, United States

Location

Cypress Ambulatory Surgery Center

Santa Maria, California, 93454, United States

Location

Orthopedic Pain Specialists

Santa Monica, California, 90403, United States

Location

Colorado Pain Clinic

Loveland, Colorado, 80538, United States

Location

St. Francis Pain Center

Wilmington, Delaware, 19713, United States

Location

Clearwater Pain Management

Clearwater, Florida, 33756, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32953, United States

Location

AMPM Research Clinic

Miami, Florida, 33169, United States

Location

Kennedy-White Orthopaedic Center

Sarasota, Florida, 34232, United States

Location

JM Clinical Research

South Miami, Florida, 33143, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Shepherd Center, Inc

Atlanta, Georgia, 30309, United States

Location

Exodus Pain Clinic

Boise, Idaho, 83713, United States

Location

Thompson and Chou Center for PM&R

Louisville, Kentucky, 40204, United States

Location

Ana Pain Management

Clinton Township, Michigan, 48038, United States

Location

Kozmary Center for Pain Management

Las Vegas, Nevada, 89102, United States

Location

Spinal & Skeletal Pain Medicine

Utica, New York, 13502, United States

Location

The Center for Clinical Research/Carolinas Pain Institute

Winston-Salem, North Carolina, 27103, United States

Location

Integrated Pain Solutions

Columbus, Ohio, 43219, United States

Location

Summa Health System Western Reserve Hospital

Cuyahoga Falls, Ohio, 44223, United States

Location

Ashland Neurosurgery

Ashland, Oregon, 97520, United States

Location

Cedar Sinai Medical Center

Ashland, Oregon, 97520, United States

Location

OAG Interventional Pain Consultants

Portland, Oregon, 97209, United States

Location

Oregon Anesthesiologist Group Interventional Pain Consultants

Portland, Oregon, 97209, United States

Location

Einstein Physician Practice, Inc.

Elkins Park, Pennsylvania, 19027, United States

Location

DNA Advanced Pain Treatment Center

Greensburg, Pennsylvania, 15601, United States

Location

Houston Pain Associates

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Space City Pain Specialists LLP

Webster, Texas, 77598, United States

Location

Advanced Spine and Pain

Stafford, Virginia, 22554, United States

Location

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

The Center of Pain Relief Tri-State

Huntington, West Virginia, 25702, United States

Location

Anesthesia & Chronic Pain / University of Wisconsin

Madison, Wisconsin, 53718, United States

Location

Related Publications (2)

• 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: 32472137 DERIVED

• 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.

  PMID: 28449352 DERIVED

MeSH Terms

Interventions

ziconotide

Study Officials

• I-Zu Huang, MD

  Jazz Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

US (43)