OP2C : Prialt® Observatory in Clinical Practice

ICO-2019-24

Ziconotide (Prialt®) is a powerful analgesic, approved in Europe since 2005, and reserved for the intrathecal route. Ziconotide is a protein of 2500 Daltons isolated from a cone-snail: Conus Magus, acting by blocking the N-type voltage-sensitive calcium channels. Its efficacy has been proven by 3 randomized clinical trials. It is particularly effective on chronic refractory 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. However, during these studies many adverse reactions became evident, especially neuropsychiatric reactions, which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment. There is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide in different settings of patients with severe chronic pain requiring intrathecal analgesia.

2020-07-10

2027-01-01

2027-01-01

Recruiting

300

Inclusion Criteria: * Age ≥ 18 years old * Severe refractory chronic pain requiring intrathecal analgesia * Candidate for intrathecal analgesia treatment with ziconotide * Patient informed about the study and agreeing to take part in. Exclusion Criteria: * Contraindications to ziconotide

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '4 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-08-01