RecruitingNCT06541184

Ziconotide for Non-cancer Pain by Intrathecal Administration


Sponsor

ESTEVE Pharmaceuticals SAS

Enrollment

85 participants

Start Date

Oct 30, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥18 years,
  • Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
  • Having received information on and not opposed to data collection,
  • Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment
  • 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 Criteria3

  • Contraindication to intrathecal therapy or to ziconotide
  • Any condition that may jeopardize appropriate follow-up of the treatment
  • Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.

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Interventions

DRUGZiconotide [Prialt]

Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.


Locations(14)

Clinique de la Casamance

Aubagne, France

Hospices Civils de Lyon

Bron, France

Polyclinique du Parc

Caen, France

CHD Vendée

La Roche-sur-Yon, France

CH Laon

Laon, France

CHU Lille

Lille, France

Clinique Mutualiste de la Porte de l'Orient

Lorient, France

Centre Léon Bérard

Lyon, France

Hopital Saint Joseph

Paris, France

CHU Poitiers

Poitiers, France

CHU Reims

Reims, France

CH Yves Le foll

Saint-Brieuc, France

CHU St Etienne

Saint-Etienne, France

IUCT Toulouse

Toulouse, France

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NCT06541184


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