OP2C : Prialt® Observatory in Clinical Practice

Institut Cancerologie de l'Ouest

Status: Enrolling

Conditions: Refractory Pain

Treatments: Drug: Ziconotide Injection

Study type: Observational

Funder types: Other

Identifiers

NCT04321408

ICO-2019-24

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Contraindications to ziconotide