Ziconotide for Non-cancer Pain by Intrathecal Administration

Last updated: February 25, 2025
Sponsor: ESTEVE Pharmaceuticals SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Ziconotide [Prialt]

Clinical Study ID

NCT06541184
ZENITH
  • Ages > 18
  • All Genders

Study Summary

Although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. Most data on ziconotide-based intrathecal (IT) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations).

In contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series.

Due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients.

This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia.

Patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia.

The collected data will cover the first 2 years of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years,

  2. Chronic non-cancer pain requiring interventional techniques, and eligible toziconotide-containing intrathecal therapy,

  3. Having received information on and not opposed to data collection,

Inclusion criteria specific for the retrospective cohort:

Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment

Inclusion criteria specific for the prospective cohort:

Naïve of ITA and candidate to ziconotide-based ITA or already treated by IT route without ziconotide, scheduled for addition of ziconotide in the pump

Exclusion

Exclusion Criteria:

  1. Contraindication to intrathecal therapy or to ziconotide

  2. Any condition that may jeopardize appropriate follow-up of the treatment

  3. Patient under guardianship or deprived of liberty by a judicial or administrativedecision or unable to express opposition to data collection.

Study Design

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: Ziconotide [Prialt]
Phase:
Study Start date:
October 30, 2024
Estimated Completion Date:
October 30, 2029

Connect with a study center

  • Clinique de la Casamance

    Aubagne,
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Bron,
    France

    Active - Recruiting

  • Polyclinique du Parc

    Caen,
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • CH Laon

    Laon,
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • Clinique Mutualiste de la Porte de l'Orient

    Lorient,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Hopital Saint Joseph

    Paris,
    France

    Site Not Available

  • CHU Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU Reims

    Reims,
    France

    Site Not Available

  • CH Yves Le foll

    Saint-Brieuc,
    France

    Active - Recruiting

  • CHU St Etienne

    St Etienne,
    France

    Active - Recruiting

  • IUCT Toulouse

    Toulouse,
    France

    Site Not Available

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