OP2C : Prialt® Observatory in Clinical Practice

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Cancerologie de l'Ouest

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Contraindications to ziconotide

Trial design

Treatments tested in this trial

  • Ziconotide Injection

Treatment groups

No treatment groups listed

Sponsors and collaborators