Clinical trial NCT02268812: Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Management
Severe Chronic Pain
Keywords: Pain Management
Europe
Intrathecal
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have a diagnosis of severe, chronic pain for which intrathecal infusion is indicated.

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)
timeFrame: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)
Secondary outcomes:
measure: Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5)
timeFrame: Baseline (Visit 1) to Month 12 (Visit 5)
measure: Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit
timeFrame: Baseline (Visit 1) to Termination Visit (12 Months after last participant was enrolled)
measure: Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.
Other outcomes:
measure: Changes in Primary Intrathecal Drug, Including Dose Adjustment and Intervals
timeFrame: 12 months after the last patient was enrolled
measure: Change in the Actual Overall EuroQoL (EQ-5D) Health Score From First Visit to Month 12 and End of Study
timeFrame: Month 12 Visit, End of Study (Termination Visit)
Locations:
Study officials:
References: