Clinical trial NCT01888120: Patient Registry of Intrathecal Ziconotide Management(PRIZM)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Severe Chronic Pain
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 140 patients will be enrolled at approximatley 50 sites in the United States.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 Weeks
Secondary outcomes:
measure: Evaluate the following from the patient's perspective via patient reported outcomes (PROs)
timeFrame: From week 12, every 3 months up to month 18
measure: Evaluate the patient's global impression of change (PGIC) with PRIALT treatment
timeFrame: From week 12, every 3 months up to month 18
measure: Evaluate changes in concomitant pain medication use
timeFrame: From week 12, every 3 months up to month 18
measure: Evaluate long-term safety and tolerability data, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From week 12, every 3 months up to month 18
measure: 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.
timeFrame: From week 12, every 3 months up to month 18
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Tennessee Valley Pain Consultants
state: Alabama
city: Chandler
country: United States
facility: Valley Pain Specialists
state: Arizona
city: Mesa
country: United States
facility: Desert Pain Institute
state: Arizona
city: Scottsdale
country: United States
facility: Valley Pain Specialists
state: Arizona
city: Batesville
country: United States
facility: White River Health System
state: Arkansas
city: Sherwood
country: United States
facility: United Pain Care
state: Arkansas
city: Carlsbad
country: United States
facility: Coastal Pain Research
state: California
city: Chino
country: United States
facility: Pain Therapy Solutions
state: California
city: Fountain Valley
country: United States
facility: Pain Medicine Associates, Inc.
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Napa
country: United States
facility: Napa Pain Institute
state: California
city: Santa Maria
country: United States
facility: Cypress Ambulatory Surgery Center
state: California
city: Santa Monica
country: United States
facility: Orthopedic Pain Specialists
state: California
city: Loveland
country: United States
facility: Colorado Pain Clinic
state: Colorado
city: Wilmington
country: United States
facility: St. Francis Pain Center
state: Delaware
city: Clearwater
country: United States
facility: Clearwater Pain Management
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Miami
country: United States
facility: AMPM Research Clinic
state: Florida
city: Sarasota
country: United States
facility: Kennedy-White Orthopaedic Center
state: Florida
city: South Miami
country: United States
facility: JM Clinical Research
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center, Inc
state: Georgia
city: Boise
country: United States
facility: Exodus Pain Clinic
state: Idaho
city: Louisville
country: United States
facility: Thompson and Chou Center for PM&R
state: Kentucky
city: Clinton Township
country: United States
facility: Ana Pain Management
state: Michigan
city: Las Vegas
country: United States
facility: Kozmary Center for Pain Management
state: Nevada
city: Utica
country: United States
facility: Spinal & Skeletal Pain Medicine
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research/Carolinas Pain Institute
state: North Carolina
city: Columbus
country: United States
facility: Integrated Pain Solutions
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Summa Health System Western Reserve Hospital
state: Ohio
city: Ashland
country: United States
facility: Ashland Neurosurgery
state: Oregon
city: Ashland
country: United States
facility: Cedar Sinai Medical Center
state: Oregon
city: Portland
country: United States
facility: OAG Interventional Pain Consultants
state: Oregon
city: Portland
country: United States
facility: Oregon Anesthesiologist Group Interventional Pain Consultants
state: Oregon
city: Elkins Park
country: United States
facility: Einstein Physician Practice, Inc.
state: Pennsylvania
city: Greensburg
country: United States
facility: DNA Advanced Pain Treatment Center
state: Pennsylvania
city: Houston
country: United States
facility: Houston Pain Associates
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Webster
country: United States
facility: Space City Pain Specialists LLP
state: Texas
city: Stafford
country: United States
facility: Advanced Spine and Pain
state: Virginia
city: Charleston
country: United States
facility: The Center for Pain Relief
state: West Virginia
city: Huntington
country: United States
facility: The Center of Pain Relief Tri-State
state: West Virginia
city: Madison
country: United States
facility: Anesthesia & Chronic Pain / University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Jazz Pharmaceuticals
name: I-Zu Huang, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.