Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 8:11 PM
Study NCT ID:
NCT04321408
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OP2C : Prialt® Observatory in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010148', 'term': 'Pain, Intractable'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078452', 'term': 'ziconotide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the practical methods of using intrathecal treatments containing ziconotide: indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment, efficacy and safety in the real clinical practice and monitoring.', 'timeFrame': '7 years', 'description': 'Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.'}], 'secondaryOutcomes': [{'measure': 'Describe the tolerability to intrathecal ziconotide treatment', 'timeFrame': '7 years', 'description': 'Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit'}, {'measure': 'Describe the efficacy on pain of intrathecal ziconotide treatment', 'timeFrame': '7 years', 'description': 'The efficacy of the analgesic treatment is measured based on the numeric pain rating scale (0 to 10) at start of Ziconotide, 1, 3, 6, 12 months, and every 12 months thereafter'}, {'measure': 'Estimate the duration of treatment according to the indication', 'timeFrame': '7 years', 'description': 'Time between the first and last date of administration of intrathecal ziconotide during study.'}, {'measure': 'Subgroup comparative analysis', 'timeFrame': '7 years', 'description': 'Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability.'}, {'measure': 'Responders profile detection', 'timeFrame': '7 years', 'description': 'Responders profile according to efficacy on pain of intrathecal ziconotide treatment'}, {'measure': 'Describe quality of life under ziconotide treatment', 'timeFrame': '7 years', 'description': 'f) The Quality of life will be assessed by EQ5D-5L questionnaires under intrathecal ziconotide treatment, at 1, 3, 6, 12 months, and every 12 months thereafter until the registry remains open'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrathecal analgesia', 'Ziconotide'], 'conditions': ['Refractory Pain']}, 'descriptionModule': {'briefSummary': 'Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies.\n\nIt is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis.\n\nHowever, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration).\n\nIn recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options.\n\nHowever, there is a lack of data on the current use of ziconotide in current practice.\n\nThe objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Severe refractory chronic pain requiring intrathecal analgesia\n* Candidate for intrathecal analgesia treatment with ziconotide\n* Patient informed about the study and agreeing to take part in.\n\nExclusion Criteria:\n\n* Contraindications to ziconotide'}, 'identificationModule': {'nctId': 'NCT04321408', 'acronym': 'OP2C', 'briefTitle': 'OP2C : Prialt® Observatory in Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'OP2C : Prialt® Observatory in Clinical Practice', 'orgStudyIdInfo': {'id': 'ICO-2019-24'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ziconotide Injection', 'type': 'DRUG', 'otherNames': ['Prialt'], 'description': 'Intrathecal analgesia with Ziconotide'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': "Institut de Cancerologie de L'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Departemental La Roche Sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '69008', 'city': 'Lyon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34298', 'city': 'Montpellier', 'status': 'SUSPENDED', 'country': 'France', 'facility': 'Institut de Cancerologie de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'status': 'SUSPENDED', 'country': 'France', 'facility': 'Clinique Breteche', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06003', 'city': 'Nice', 'status': 'SUSPENDED', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '92210', 'city': 'Saint-Cloud', 'status': 'SUSPENDED', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '92151', 'city': 'Suresnes', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Hopital - Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Barbara Kleinmann, MD', 'role': 'CONTACT', 'email': 'barbara.kleinmann@uniklinik-freiburg.de'}, {'name': 'Barbara Kleinmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '353902', 'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Malgorzata Kolodziej, MD', 'role': 'CONTACT', 'email': 'malgorzata.kolodziej@neuro.med.uni-giessen.de'}, {'name': 'Malgorzata Kolodziej, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Justus-Liebig-Universitat', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '07747', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Falko Schwarz, MD', 'role': 'CONTACT', 'email': 'Falko.Schwarz@med.uni-jena.de'}, {'name': 'Falko Schwarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '11009', 'city': 'Cadiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Manuel Trinidad Martin- Arroyo, MD', 'role': 'CONTACT', 'email': 'jmtrinidad80@gmail.com'}, {'name': 'Jose Manuel Trinidad Martin- Arroyo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Puerta Del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '30202', 'city': 'Cartagena', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Luz Padilla Del Rey, MD', 'role': 'CONTACT', 'email': 'mariluzpadilladelrey@gmail.com'}, {'name': 'Maria Luz Padilla Del Rey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario Santa Lucía', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'zip': '18014', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Gálvez Mateos, MD', 'role': 'CONTACT', 'email': 'rafaelgalvez@hotmail.com'}, {'name': 'Rafael Gálvez Mateos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '32005', 'city': 'Ourense', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Luz Cánovas Martinez, MD', 'role': 'CONTACT', 'email': 'luzourense2020@gmail.com'}, {'name': 'María Luz Cánovas Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Complexo Hospitalario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'ISAAC PENA VERGARA, MD', 'role': 'CONTACT', 'email': 'isaacpv@gmail.com'}, {'name': 'ISAAC PENA VERGARA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Carlos Tornero Tornero, MD', 'role': 'CONTACT', 'email': 'carlostornero@gmail.com'}, {'name': 'Juan Carlos Tornero Tornero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'DENIS DUPOIRON, MD', 'role': 'CONTACT', 'email': 'denis.dupoiron@ico.unicancer.fr', 'phone': '+33 241352700', 'phoneExt': '+33'}, {'name': 'MARINE TIGREAT', 'role': 'CONTACT', 'email': 'marine.tigreat@ico.unicancer.fr', 'phone': '+33 240679878', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'DENIS DUPOIRON, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Institut de Canérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'collaborators': [{'name': 'Esteve', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}