OP2C : Prialt® Observatory in Clinical Practice

Overview

Ziconotide is a powerful analgesic marketed since 2009 in France and reserved for the intrathecal route.

It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of spinal toxicity and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug or tachyphylaxis.

However, during these studies many undesirable effects were highlighted, especially neuropsychic which limited its use. This toxicity was mainly related to the administration of too high doses.

In recent years, the use of ziconotide intrathecally has again become a relevant option. Indeed, it is recommended as a first line in 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.

Full Title of Study: “OP2C : Prialt® Observatory in Clinical Practice”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2023

Interventions

  • Drug: Ziconotide Injection
    • intrathecal analgesia with Ziconotide

Clinical Trial Outcome Measures

Primary Measures

  • Describe the practical methods of using intrathecal treatments containing ziconotide
    • Time Frame: 1 year
    • indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years old
  • Severe refractory chronic pain
  • Candidate for intrathecal analgesia treatment with ziconotide
  • Patient informed about the study and who does not oppose it

Exclusion Criteria

  • Contraindications to ziconotide

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Cancerologie de l’Ouest
  • Collaborator
    • Keocyt
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • DENIS DUPOIRON, MD, +33 241352700, denis.dupoiron@ico.unicancer.fr

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