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OP2C : Prialt® Observatory in Clinical Practice
Sponsor: Institut Cancerologie de l'Ouest
Summary
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. It 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. However, 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). In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options. However, 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2020-07-10
Completion Date
2027-09
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Ziconotide Injection
Intrathecal analgesia with Ziconotide
Locations (17)
Institut de Cancerologie de L'Ouest
Angers, France
Centre Hospitalier Departemental La Roche Sur Yon
La Roche-sur-Yon, France
Centre Leon Berard
Lyon, France
Institut de Cancerologie de Montpellier
Montpellier, France
Clinique Breteche
Nantes, France
CHU NICE
Nice, France
Institut Curie
Saint-Cloud, France
Hopital - Foch
Suresnes, France
University of Freiburg
Freiburg im Breisgau, Germany
Justus-Liebig-Universitat
Giessen, Germany
Jena University Hospital
Jena, Germany
Hospital Universitario Puerta Del Mar
Cadiz, Spain
Hospital General Universitario Santa Lucía
Cartagena, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Complexo Hospitalario de Ourense
Ourense, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain