Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain. (PRIME)

Patient Registry of Intrathecal Pain Management in Europe: An Open-label, Long-term, Multi-center, Multi-national Post-marketing Observational Study of the Use of Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.

This is an open-label, long-term, multi-center multi-national post-marketing observational registry. The objective of this study is to monitor the long-term efficacy, safety, tolerability and quality of life outcomes associated with ziconotide (Prialt) and other analgesics utilized in the intrathecal (IT) management of severe chronic pain.

Study Overview

• Status: Completed
• Conditions: Pain Management; Severe Chronic Pain

Detailed Description

This is an observational non-interventional registry. All patients will sign and date an Informed Consent Form (ICF) before enrollment (Baseline Visit). Normal clinical practice will be followed. Patients will continue to follow their usual schedule of clinic visits as determined by their physician, during which information and patient-completed questionnaires will be collected (at scheduled intervals timed to coincide with pump refill).

• Study Type: Observational
• Enrollment (Actual): 219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that have a diagnosis of severe, chronic pain for which intrathecal infusion is indicated.

Description

Inclusion Criteria

Patients will be eligible to enroll onto the registry if they have given informed consent and meet the following criteria:

• Patient's physician has deemed that the initiation/switch of intrathecal analgesia appropriate, or patient is presently utilizing ziconotide (Prialt)
• Patient has a diagnosis of severe, chronic pain for which intrathecal infusion is indicated
• Patient is at least 18 years of age at time of study entry

All patients starting ziconotide (Prialt) should comply with the indications and warnings in the current approved version of the Summary of Product Characteristics (SmPC).

Exclusion Criteria

Patients who meet any of the following criteria will not be eligible to enroll in the registry:

• Patient is a pregnant or lactating female
• Patient is receiving intrathecal chemotherapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ziconotide; No drug will be provided by the sponsor. Treatment decisions will be made by physicians independent of participation in the registry. IT analgesia may consist of ziconotide or any other drug used in IT therapy, including those used off-label as part of local clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)	VASPI is a worldwide validated measure of pain intensity. A Visual Analog Score (VAS) for pain is determined by using a horizontal line, 100-millimeter (mm) in length, anchored by word descriptors at each end; "no pain" (0 mm) on the left end and "worst imaginable pain" (100 mm) on the right end. The participant was asked to mark on the line the point that they feel represents their current state of pain. A VAS for least pain (over last two weeks), usual pain (over last two weeks), and pain today was determined and averaged to derive the total VAS score ranging from 0 (no pain) to 100 (worst pain imaginable). A last observation carried forward (LOCF) dataset was used to account for missing data where First Visit data could be carried forward.	Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5)	The Brief Pain Inventory-Short Form (BPI-SF) survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was "no pain" and 10 was "pain as bad as you can imagine" for each item listed. The pain interference survey scored each item on a scale, where 0 was "does not interfere" to 10 was "completely interferes". The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.	Baseline (Visit 1) to Month 12 (Visit 5)
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit	The BPI-SF survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was "no pain" and 10 was "pain as bad as you can imagine" for each item listed. The pain interference survey scored each item on a scale, where 0 was "does not interfere" to 10 was "completely interferes". The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.	Baseline (Visit 1) to Termination Visit (12 Months after last participant was enrolled)
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)	Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), any therapeutic interventions including all drug therapies, vital signs, and creatine kinase (CK) if laboratory tests were taken by the physician as part of routine clinical practice. AEs were graded on a 3-point scale; 1) mild - discomfort noticed, but no disruption of normal daily activity, 2) moderate - discomfort sufficient to reduce or affect normal daily activity, 3) severe - incapacitating, with inability to work or to perform normal daily activity. A TEAE was defined as an adverse event (AE) with a start date on or after the date of the First Visit. Where a start date was missing, the AE was considered to be treatment-emergent.	From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Primary Intrathecal Drug, Including Dose Adjustment and Intervals	Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.	12 months after the last patient was enrolled
Change in the Actual Overall EuroQoL (EQ-5D) Health Score From First Visit to Month 12 and End of Study	The EQ-5D is a standardized instrument used to measure quality of life. It classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain has three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state was defined by combining one level from each of the five dimensions. The response to the question of how good or bad the participant's health was today was given on a visual analogue scale of 0 to 100 millimeters (mm), where 0 meant the participant was in the worst imaginable health state today and 100 meant the participant was in the best imaginable health state today. The results for the Health Score were that of the calculated overall score of the five dimensions, where -0.594 is worst health and 1.00 is perfect health. Change is defined as change in actual from the First Visit.	Month 12 Visit, End of Study (Termination Visit)

Collaborators and Investigators

• Sponsor: Eisai Limited

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pain Management; Europe; Intrathecal
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: SNX-111-E044-401