RecruitingNCT04321408

OP2C : Prialt® Observatory in Clinical Practice


Sponsor

Institut Cancerologie de l'Ouest

Enrollment

300 participants

Start Date

Jul 10, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • Contraindications to ziconotide

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Interventions

DRUGZiconotide 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

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NCT04321408


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