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

An observational study of Pain Management and Severe Chronic Pain, run by Eisai Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain Management, Severe Chronic Pain
How many people: 219 participants
Where: No sites listed yet
Study dates: Apr 2008to Jul 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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).

Who cannot join

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

About this study

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.

Read the 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).

Conditions: Pain Management, Severe Chronic Pain
Keywords: Pain Management, Europe, Intrathecal
Medical subject headings: Agnosia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02268812
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jul 2012

First posted20 Oct 2014 (estimated)
Study startApr 2008
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain ManagementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02268812
Sponsor's protocol ID: SNX-111-E044-401
Acronym: PRIME
Status last verified: Jan 2018
First submitted: 16 Oct 2014
Last updated: 25 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain Management trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02268812
Acronym / sponsor ID: PRIME / SNX-111-E044-401
Conditions: Pain Management, Severe Chronic Pain
Keywords: Pain Management, Europe, Intrathecal
Study type: Observational
Recruitment status: Completed
Enrolment: 219 participants (actual)
Lead sponsor: Eisai LimitedIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 20 Oct 2014 (estimated)
Results: Posted 25 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients that have a diagnosis of severe, chronic pain for which intrathecal infusion is indicated.

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)
Time frame: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)
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.

3 secondary outcomes

Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5)
Time frame: Baseline (Visit 1) to Month 12 (Visit 5)
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit
Time frame: 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)
Time frame: From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.

Results and safety

Results posted to the registry on 25 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ziconotide Monotherapy	77	61
Ziconotide Combination	72	40
Other IT Monotherapy	30	21
Other IT Combination	40	26

Primary outcome: Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)

Time frame: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled). Mean (Standard Deviation). Unit: Units on a scale

Measure	Ziconotide Monotherapy n = 83	Ziconotide Combination n = 114	Other IT Monotherapy n = 67	Other IT Combination n = 71
Month 8 (Visit 4)	-3.23 (23.160)	-15.24 (23.614)	-1.50 (20.736)	-18.40 (21.899)
Month 12 (Visit 5)	-3.78 (23.424)	-9.33 (30.039)	1.67 (20.894)	-14.33 (29.800)
Termination Visit	-6.01 (23.220)	0.65 (28.208)	1.64 (21.643)	-14.27 (34.620)

Population analysed: Intent-to-Treat (ITT) (LOCF) population included all participants who had at least one dose of an IT therapy. Total number of participants for the outcome measures (335) does not match the total number enrolled (219) due to participants switching between treatment arms as allowed per protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziconotide Monotherapy	26 of 83 (31.3%)	59 of 83 (71.1%)	3 of 83
Ziconotide Combination	51 of 114 (44.7%)	70 of 114 (61.4%)	26 of 114
Other IT Monotherapy	24 of 67 (35.8%)	34 of 67 (50.7%)	7 of 67
Other IT Combination	30 of 71 (42.3%)	43 of 71 (60.6%)	12 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain Management and Severe Chronic Pain, run by Eisai Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) (time frame: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02268812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.