Patient Registry of Intrathecal Ziconotide Management(PRIZM)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Patients With Severe Chronic Pain

Intervention / Treatment
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* Drug: Ziconotide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe Chronic Pain<br> | Drug: Ziconotide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |