OP2C : Prialt® Observatory in Clinical Practice

Last updated: August 13, 2025
Sponsor: Institut Cancerologie de l'Ouest
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Ziconotide Injection

Clinical Study ID

NCT04321408
ICO-2019-24
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Contraindications to ziconotide

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Ziconotide Injection
Phase:
Study Start date:
July 10, 2020
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Institut de Cancerologie de L'Ouest

    Angers, 49000
    France

    Site Not Available

  • Centre Hospitalier Departemental La Roche Sur Yon

    La Roche-sur-Yon, 85000
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69008
    France

    Site Not Available

  • Institut de Cancerologie de Montpellier

    Montpellier, 34298
    France

    Suspended

  • Clinique Breteche

    Nantes, 44000
    France

    Suspended

  • CHU NICE

    Nice, 06003
    France

    Suspended

  • Institut Curie

    Saint-Cloud, 92210
    France

    Suspended

  • Hopital - Foch

    Suresnes, 92151
    France

    Site Not Available

  • University of Freiburg

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Justus-Liebig-Universitat

    Gießen, 353902
    Germany

    Active - Recruiting

  • Jena University Hospital

    Jena, 07747
    Germany

    Active - Recruiting

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital General Universitario Santa Lucía

    Cartagena, 30202
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Complexo Hospitalario de Ourense

    Ourense, 32005
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

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