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

NCT02268812 | Completed Results

• 1 other identifier: SNX-111-E044-401
• Study Type: observational
• Target: 219
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain Management; Severe Chronic Pain

Keywords

Pain Management; Europe; Intrathecal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5)

  Baseline (Visit 1) to Month 12 (Visit 5)

• Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit

  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)

  From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.

Other Outcomes (2)

• Changes in Primary Intrathecal Drug, Including Dose Adjustment and Intervals

  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

  Month 12 Visit, End of Study (Termination Visit)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Limited: lead

MeSH Terms

Conditions

Agnosia; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai Europe Ltd.

+44 (0)20 8600 1400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: April 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 25, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-01