Patients With Severe Chronic Pain
Conditions
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.
Interventions
DRUGZiconotide
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed