Patients With Severe Chronic Pain Clinical Trial
— PRIZMOfficial 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
| Verified date | March 2017 |
| Source | Jazz Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | March 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ashland Neurosurgery | Ashland | Oregon |
| United States | Cedar Sinai Medical Center | Ashland | Oregon |
| United States | Shepherd Center, Inc | Atlanta | Georgia |
| United States | White River Health System | Batesville | Arkansas |
| United States | Exodus Pain Clinic | Boise | Idaho |
| United States | Coastal Pain Research | Carlsbad | California |
| United States | Valley Pain Specialists | Chandler | Arizona |
| United States | The Center for Pain Relief | Charleston | West Virginia |
| United States | Pain Therapy Solutions | Chino | California |
| United States | Clearwater Pain Management | Clearwater | Florida |
| United States | Ana Pain Management | Clinton Township | Michigan |
| United States | Integrated Pain Solutions | Columbus | Ohio |
| United States | Summa Health System Western Reserve Hospital | Cuyahoga Falls | Ohio |
| United States | Einstein Physician Practice, Inc. | Elkins Park | Pennsylvania |
| United States | Pain Medicine Associates, Inc. | Fountain Valley | California |
| United States | DNA Advanced Pain Treatment Center | Greensburg | Pennsylvania |
| United States | Houston Pain Associates | Houston | Texas |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | The Center of Pain Relief Tri-State | Huntington | West Virginia |
| United States | Tennessee Valley Pain Consultants | Huntsville | Alabama |
| United States | University of California, San Diego | La Jolla | California |
| United States | Kozmary Center for Pain Management | Las Vegas | Nevada |
| United States | Thompson and Chou Center for PM&R | Louisville | Kentucky |
| United States | Colorado Pain Clinic | Loveland | Colorado |
| United States | Anesthesia & Chronic Pain / University of Wisconsin | Madison | Wisconsin |
| United States | Florida Pain Institute | Merritt Island | Florida |
| United States | Desert Pain Institute | Mesa | Arizona |
| United States | AMPM Research Clinic | Miami | Florida |
| United States | Napa Pain Institute | Napa | California |
| United States | OAG Interventional Pain Consultants | Portland | Oregon |
| United States | Oregon Anesthesiologist Group Interventional Pain Consultants | Portland | Oregon |
| United States | Cypress Ambulatory Surgery Center | Santa Maria | California |
| United States | Orthopedic Pain Specialists | Santa Monica | California |
| United States | Kennedy-White Orthopaedic Center | Sarasota | Florida |
| United States | Valley Pain Specialists | Scottsdale | Arizona |
| United States | United Pain Care | Sherwood | Arkansas |
| United States | JM Clinical Research | South Miami | Florida |
| United States | Advanced Spine and Pain | Stafford | Virginia |
| United States | Tallahassee Neurological Clinic | Tallahassee | Florida |
| United States | Spinal & Skeletal Pain Medicine | Utica | New York |
| United States | Space City Pain Specialists LLP | Webster | Texas |
| United States | St. Francis Pain Center | Wilmington | Delaware |
| United States | The Center for Clinical Research/Carolinas Pain Institute | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Jazz Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Evaluate the following from the patient's perspective via patient reported outcomes (PROs) | From week 12, every 3 months up to month 18 | ||
| Secondary | Evaluate the patient's global impression of change (PGIC) with PRIALT treatment | From week 12, every 3 months up to month 18 | ||
| Secondary | Evaluate changes in concomitant pain medication use | From week 12, every 3 months up to month 18 | ||
| Secondary | 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 | ||
| Secondary | 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 |