Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT01888120
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2013-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Registry of Intrathecal Ziconotide Management(PRIZM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, 'interventionBrowseModule': {'meshes': [{'id': 'C078452', 'term': 'ziconotide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2013-06-25', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': "Evaluate the following from the patient's perspective via patient reported outcomes (PROs)", 'timeFrame': 'From week 12, every 3 months up to month 18'}, {'measure': "Evaluate the patient's global impression of change (PGIC) with PRIALT treatment", 'timeFrame': 'From week 12, every 3 months up to month 18'}, {'measure': 'Evaluate changes in concomitant pain medication use', 'timeFrame': 'From week 12, every 3 months up to month 18'}, {'measure': 'Evaluate long-term safety and tolerability data, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From week 12, every 3 months up to month 18'}, {'measure': '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.', 'timeFrame': 'From week 12, every 3 months up to month 18'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients With Severe Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '32472137', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28449352', 'type': 'DERIVED', 'citation': 'Deer 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 140 patients will be enrolled at approximatley 50 sites in the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age at the time of study entry.\n* 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.\n* Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.\n* Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.\n* Patient has a life expectancy \\>6 months as determined by the physician.\n* Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.\n* Patient is able to understand and complete required assessments.\n\nExclusion Criteria:\n\n* Patient has a known hypersensitivity to PRIALT or any of its formulation components.\n* Patient has a pre-existing history of psychosis.\n* Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.\n* Patient is being initiated with PRIALT in conjunction with other IT agents.\n* Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.'}, 'identificationModule': {'nctId': 'NCT01888120', 'acronym': 'PRIZM', 'briefTitle': 'Patient Registry of Intrathecal Ziconotide Management(PRIZM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '13-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe Chronic Pain', 'interventionNames': ['Drug: Ziconotide']}], 'interventions': [{'name': 'Ziconotide', 'type': 'DRUG', 'armGroupLabels': ['Severe Chronic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Tennessee Valley Pain Consultants', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Valley Pain Specialists', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Pain Institute', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85006', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Valley Pain Specialists', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72501', 'city': 'Batesville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'White River Health System', 'geoPoint': {'lat': 35.7698, 'lon': -91.64097}}, {'zip': '72120', 'city': 'Sherwood', 'state': 'Arkansas', 'country': 'United States', 'facility': 'United Pain Care', 'geoPoint': {'lat': 34.81509, 'lon': -92.22432}}, {'zip': '92009', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Pain Research', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Pain Therapy Solutions', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Pain Medicine Associates, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94558', 'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Napa Pain Institute', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Cypress Ambulatory Surgery Center', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Orthopedic Pain Specialists', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Pain Clinic', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '19713', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'St. Francis Pain Center', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Pain Management', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32953', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Pain Institute', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'AMPM Research Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Kennedy-White Orthopaedic Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'JM Clinical Research', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Neurological Clinic', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center, Inc', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83713', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Exodus Pain Clinic', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '40204', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Thompson and Chou Center for PM&R', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ana Pain Management', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Kozmary Center for Pain Management', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '13502', 'city': 'Utica', 'state': 'New York', 'country': 'United States', 'facility': 'Spinal & Skeletal Pain Medicine', 'geoPoint': {'lat': 43.1009, 'lon': -75.23266}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research/Carolinas Pain Institute', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43219', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Integrated Pain Solutions', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44223', 'city': 'Cuyahoga Falls', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Health System Western Reserve Hospital', 'geoPoint': {'lat': 41.13394, 'lon': -81.48456}}, {'zip': '97520', 'city': 'Ashland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Ashland Neurosurgery', 'geoPoint': {'lat': 42.19458, 'lon': -122.70948}}, {'zip': '97520', 'city': 'Ashland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Cedar Sinai Medical Center', 'geoPoint': {'lat': 42.19458, 'lon': -122.70948}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OAG Interventional Pain Consultants', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Anesthesiologist Group Interventional Pain Consultants', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19027', 'city': 'Elkins Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Physician Practice, Inc.', 'geoPoint': {'lat': 40.07706, 'lon': -75.12684}}, {'zip': '15601', 'city': 'Greensburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DNA Advanced Pain Treatment Center', 'geoPoint': {'lat': 40.30146, 'lon': -79.53893}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Pain Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Space City Pain Specialists LLP', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '22554', 'city': 'Stafford', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advanced Spine and Pain', 'geoPoint': {'lat': 38.42207, 'lon': -77.40832}}, {'zip': '25301', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'The Center for Pain Relief', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'zip': '25702', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'The Center of Pain Relief Tri-State', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'zip': '53718', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Anesthesia & Chronic Pain / University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'I-Zu Huang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jazz Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}