Informations générales (source: ClinicalTrials.gov)

NCT04321408 En recrutement IDF
OP2C : Prialt® Observatory in Clinical Practice (OP2C)
Observational [Patient Registry]
  • Douleur rebelle
Institut Cancerologie de l'Ouest (Voir sur ClinicalTrials)
juillet 2020
septembre 2027
19 juillet 2024
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.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH NAOUFEL OUERCHEFANI En recrutement IDF 05/05/2025 07:12:06  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CLCC RENE HUGUENIN INSTITUT CURIE Suspendu Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Departemental La Roche Sur Yon - 85000 - La Roche-sur-Yon - France Yves Marie PLUCHON, MD En recrutement Contact (sur clinicalTrials)
Centre Leon Berard - 69008 - Lyon - France Gisèle CHVETZOFF, MD En recrutement Contact (sur clinicalTrials)
CHU NICE - 06003 - Nice - France Suspendu Contact (sur clinicalTrials)
Clinique Breteche - 44000 - Nantes - France Suspendu Contact (sur clinicalTrials)
Institut de Cancerologie de L'Ouest - 49000 - Angers - France DENIS DUPOIRON, MD En recrutement Contact (sur clinicalTrials)
Institut de Cancerologie de Montpellier - 34298 - Montpellier - France Suspendu Contact (sur clinicalTrials)

Critères

Tous
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.



- Contraindications to ziconotide