Patients With Severe Chronic PainPRIZMNCT01888120
Patient Registry of Intrathecal Ziconotide Management(PRIZM)
An observational study of Patients With Severe Chronic Pain, run by Jazz Pharmaceuticals at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Severe Chronic Pain
- What is being tested?
- Ziconotide
- How many people
- 93 participants
- Where
- 43 sitesUnited States
- Study dates
- Jul 2013to Mar 2017
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Up to 140 patients will be enrolled at approximatley 50 sites in the United States.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Ashland Neurosurgery
Ashland, Oregon, 97520
Cedar Sinai Medical Center
Ashland, Oregon, 97520
Shepherd Center, Inc
Atlanta, Georgia, 30309
White River Health System
Batesville, Arkansas, 72501
Exodus Pain Clinic
Boise, Idaho, 83713
Coastal Pain Research
Carlsbad, California, 92009
Valley Pain Specialists
Chandler, Arizona, 85224
The Center for Pain Relief
Charleston, West Virginia, 25301
Pain Therapy Solutions
Chino, California, 91710
Clearwater Pain Management
Clearwater, Florida, 33756
Ana Pain Management
Clinton Township, Michigan, 48038
Integrated Pain Solutions
Columbus, Ohio, 43219
Summa Health System Western Reserve Hospital
Cuyahoga Falls, Ohio, 44223
Einstein Physician Practice, Inc.
Elkins Park, Pennsylvania, 19027
Pain Medicine Associates, Inc.
Fountain Valley, California, 92708
DNA Advanced Pain Treatment Center
Greensburg, Pennsylvania, 15601
Houston Pain Associates
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
The Center of Pain Relief Tri-State
Huntington, West Virginia, 25702
Tennessee Valley Pain Consultants
Huntsville, Alabama, 35801
University of California, San Diego
La Jolla, California, 92037
Kozmary Center for Pain Management
Las Vegas, Nevada, 89102
Thompson and Chou Center for PM&R
Louisville, Kentucky, 40204
Colorado Pain Clinic
Loveland, Colorado, 80538
Anesthesia & Chronic Pain / University of Wisconsin
Madison, Wisconsin, 53718
Florida Pain Institute
Merritt Island, Florida, 32953
Desert Pain Institute
Mesa, Arizona, 85206
AMPM Research Clinic
Miami, Florida, 33169
Napa Pain Institute
Napa, California, 94558
OAG Interventional Pain Consultants
Portland, Oregon, 97209
Oregon Anesthesiologist Group Interventional Pain Consultants
Portland, Oregon, 97209
Cypress Ambulatory Surgery Center
Santa Maria, California, 93454
Orthopedic Pain Specialists
Santa Monica, California, 90403
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232
Valley Pain Specialists
Scottsdale, Arizona, 85006
United Pain Care
Sherwood, Arkansas, 72120
JM Clinical Research
South Miami, Florida, 33143
Advanced Spine and Pain
Stafford, Virginia, 22554
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
Spinal & Skeletal Pain Medicine
Utica, New York, 13502
Space City Pain Specialists LLP
Webster, Texas, 77598
St. Francis Pain Center
Wilmington, Delaware, 19713
The Center for Clinical Research/Carolinas Pain Institute
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Patients With Severe Chronic Pain
- Being tested
- Ziconotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiconotideDrug
| Study group | Role | What they receive |
|---|---|---|
| Severe Chronic Pain | Not described Receives: Drug: Ziconotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Weeks
Secondary outcomes (5)
Evaluate the following from the patient's perspective via patient reported outcomes (PROs)
Measured: From week 12, every 3 months up to month 18
Evaluate the patient's global impression of change (PGIC) with PRIALT treatment
Measured: From week 12, every 3 months up to month 18
Evaluate changes in concomitant pain medication use
Measured: 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)
Measured: 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.
Measured: From week 12, every 3 months up to month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With Severe Chronic PainStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- I-Zu Huang, MD, Study director, Jazz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888120
- Sponsor's protocol ID
- 13-001
- Acronym
- PRIZM
- Status last verified
- Mar 2017
- First submitted
- 25 Jun 2013
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
McDowell GC, Saulino MF, Wallace M, Grigsby EJ, Rauck RL, Kim P, Vanhove GF, Ryan R, Huang IZ, Deer T. Effectiveness and Safety of Intrathecal Ziconotide: Final Results of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Med. 2020 Nov 1;21(11):2925-2938. doi: 10.1093/pm/pnaa115.
PubMed 32472137Deer T, Rauck RL, Kim P, Saulino MF, Wallace M, Grigsby EJ, Huang IZ, Mori F, Vanhove GF, McDowell GC 2nd. Effectiveness and Safety of Intrathecal Ziconotide: Interim Analysis of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Pract. 2018 Feb;18(2):230-238. doi: 10.1111/papr.12599. Epub 2017 Jul 14.
PubMed 28449352
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01888120
- Acronym / sponsor ID
- PRIZM / 13-001
- Conditions
- Patients With Severe Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Chronic Pain | – | Drug: Ziconotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 140 patients will be enrolled at approximatley 50 sites in the United States.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziconotide | Drug | Severe Chronic Pain |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Derived from this study: PubMed 32472137McDowell GC, Saulino MF, Wallace M, Grigsby EJ, Rauck RL, Kim P, Vanhove GF, Ryan R, Huang IZ, Deer T. Effectiveness and Safety of Intrathecal Ziconotide: Final Results of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Med. 2020 Nov 1;21(11):2925-2938. doi: 10.1093/pm/pnaa115.
- Derived from this study: PubMed 28449352Deer T, Rauck RL, Kim P, Saulino MF, Wallace M, Grigsby EJ, Huang IZ, Mori F, Vanhove GF, McDowell GC 2nd. Effectiveness and Safety of Intrathecal Ziconotide: Interim Analysis of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Pract. 2018 Feb;18(2):230-238. doi: 10.1111/papr.12599. Epub 2017 Jul 14.
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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.
I-Zu Huang, MD study director
Jazz Pharmaceuticals
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Severe Chronic Pain, run by Jazz Pharmaceuticals at 43 sites in United States.
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 7 inclusion and 5 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 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT01888120, which also lists 2 linked publications.
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 16 Mar 2017.