Actively Recruiting

Age: 18Years +
All Genders
NCT04321408

OP2C : Prialt® Observatory in Clinical Practice

Led by Institut Cancerologie de l'Ouest · Updated on 2025-08-17

300

Participants Needed

17

Research Sites

372 weeks

Total Duration

On this page

Sponsors

I

Institut Cancerologie de l'Ouest

Lead Sponsor

E

Esteve

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

OP2C : Prialt® Observatory in Clinical Practice

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Contraindications to ziconotide

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Institut de Cancerologie de L'Ouest

Angers, France, 49000

Active, Not Recruiting

2

Centre Hospitalier Departemental La Roche Sur Yon

La Roche-sur-Yon, France, 85000

Active, Not Recruiting

3

Centre Leon Berard

Lyon, France, 69008

Active, Not Recruiting

4

Institut de Cancerologie de Montpellier

Montpellier, France, 34298

Suspended

5

Clinique Breteche

Nantes, France, 44000

Suspended

6

CHU NICE

Nice, France, 06003

Suspended

7

Institut Curie

Saint-Cloud, France, 92210

Suspended

8

Hopital - Foch

Suresnes, France, 92151

Active, Not Recruiting

9

University of Freiburg

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

10

Justus-Liebig-Universitat

Giessen, Germany, 353902

Actively Recruiting

11

Jena University Hospital

Jena, Germany, 07747

Actively Recruiting

12

Hospital Universitario Puerta Del Mar

Cadiz, Spain, 11009

Actively Recruiting

13

Hospital General Universitario Santa Lucía

Cartagena, Spain, 30202

Actively Recruiting

14

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Actively Recruiting

15

Hospital Complexo Hospitalario de Ourense

Ourense, Spain, 32005

Actively Recruiting

16

Hospital Universitario Virgen del Rocío

Seville, Spain

Actively Recruiting

17

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

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Research Team

D

DENIS DUPOIRON, MD

CONTACT

M

MARINE TIGREAT

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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