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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Chronic Pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziconotide | Drug |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 140 patients will be enrolled at approximatley 50 sites in the United States.
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| Name | Affiliation | Role |
|---|---|---|
| I-Zu Huang, MD | Jazz Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Valley Pain Consultants | Huntsville | Alabama | 35801 | United States | ||
| Valley Pain Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32472137 | Derived | 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. | |
| 28449352 | Derived |
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| 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 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Desert Pain Institute | Mesa | Arizona | 85206 | United States |
| Valley Pain Specialists | Scottsdale | Arizona | 85006 | United States |
| White River Health System | Batesville | Arkansas | 72501 | United States |
| United Pain Care | Sherwood | Arkansas | 72120 | United States |
| Coastal Pain Research | Carlsbad | California | 92009 | United States |
| Pain Therapy Solutions | Chino | California | 91710 | United States |
| Pain Medicine Associates, Inc. | Fountain Valley | California | 92708 | United States |
| University of California, San Diego | La Jolla | California | 92037 | United States |
| Napa Pain Institute | Napa | California | 94558 | United States |
| Cypress Ambulatory Surgery Center | Santa Maria | California | 93454 | United States |
| Orthopedic Pain Specialists | Santa Monica | California | 90403 | United States |
| Colorado Pain Clinic | Loveland | Colorado | 80538 | United States |
| St. Francis Pain Center | Wilmington | Delaware | 19713 | United States |
| Clearwater Pain Management | Clearwater | Florida | 33756 | United States |
| Florida Pain Institute | Merritt Island | Florida | 32953 | United States |
| AMPM Research Clinic | Miami | Florida | 33169 | United States |
| Kennedy-White Orthopaedic Center | Sarasota | Florida | 34232 | United States |
| JM Clinical Research | South Miami | Florida | 33143 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| Shepherd Center, Inc | Atlanta | Georgia | 30309 | United States |
| Exodus Pain Clinic | Boise | Idaho | 83713 | United States |
| Thompson and Chou Center for PM&R | Louisville | Kentucky | 40204 | United States |
| Ana Pain Management | Clinton Township | Michigan | 48038 | United States |
| Kozmary Center for Pain Management | Las Vegas | Nevada | 89102 | United States |
| Spinal & Skeletal Pain Medicine | Utica | New York | 13502 | United States |
| The Center for Clinical Research/Carolinas Pain Institute | Winston-Salem | North Carolina | 27103 | United States |
| Integrated Pain Solutions | Columbus | Ohio | 43219 | United States |
| Summa Health System Western Reserve Hospital | Cuyahoga Falls | Ohio | 44223 | United States |
| Ashland Neurosurgery | Ashland | Oregon | 97520 | United States |
| Cedar Sinai Medical Center | Ashland | Oregon | 97520 | United States |
| OAG Interventional Pain Consultants | Portland | Oregon | 97209 | United States |
| Oregon Anesthesiologist Group Interventional Pain Consultants | Portland | Oregon | 97209 | United States |
| Einstein Physician Practice, Inc. | Elkins Park | Pennsylvania | 19027 | United States |
| DNA Advanced Pain Treatment Center | Greensburg | Pennsylvania | 15601 | United States |
| Houston Pain Associates | Houston | Texas | 77030 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Space City Pain Specialists LLP | Webster | Texas | 77598 | United States |
| Advanced Spine and Pain | Stafford | Virginia | 22554 | United States |
| The Center for Pain Relief | Charleston | West Virginia | 25301 | United States |
| The Center of Pain Relief Tri-State | Huntington | West Virginia | 25702 | United States |
| Anesthesia & Chronic Pain / University of Wisconsin | Madison | Wisconsin | 53718 | United States |
| 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. |
| ID | Term |
|---|---|
| C078452 | ziconotide |
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