Overview

This trial is active, not recruiting.

Condition patients with severe chronic pain
Treatment ziconotide
Sponsor Jazz Pharmaceuticals
Start date July 2013
End date December 2016
Trial size 93 participants
Trial identifier NCT01888120, 13-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
ziconotide

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
time frame: 12 Weeks

Secondary Outcomes

Measure
Evaluate the following from the patient's perspective via patient reported outcomes (PROs)
time frame: From week 12, every 3 months up to month 18
Evaluate the patient's global impression of change (PGIC) with PRIALT treatment
time frame: From week 12, every 3 months up to month 18
Evaluate changes in concomitant pain medication use
time frame: 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)
time frame: 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.
time frame: From week 12, every 3 months up to month 18

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Jazz Pharmaceuticals.