Actively Recruiting

Age: 18Years +
All Genders
NCT06541184

Ziconotide for Non-cancer Pain by Intrathecal Administration

Led by ESTEVE Pharmaceuticals SAS · Updated on 2025-02-27

85

Participants Needed

14

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ziconotide for Non-cancer Pain by Intrathecal Administration

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Chronic non-cancer pain requiring interventional techniques and eligible for ziconotide-based intrathecal therapy
  • Provided information and did not oppose data collection
  • For retrospective group: currently treated with ziconotide-based intrathecal analgesia regardless of treatment duration
  • For prospective group: naive to intrathecal analgesia and candidate for ziconotide-based treatment, or already using intrathecal therapy without ziconotide and scheduled to add it
Not Eligible

You will not qualify if you...

  • Contraindication to intrathecal therapy or to ziconotide
  • Any condition that may prevent proper follow-up during treatment
  • Patient under guardianship, deprived of liberty by judicial or administrative decision, or unable to express opposition to data collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Clinique de la Casamance

Aubagne, France

Actively Recruiting

2

Hospices Civils de Lyon

Bron, France

Actively Recruiting

3

Polyclinique du Parc

Caen, France

Not Yet Recruiting

4

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

5

CH Laon

Laon, France

Actively Recruiting

6

CHU Lille

Lille, France

Actively Recruiting

7

Clinique Mutualiste de la Porte de l'Orient

Lorient, France

Actively Recruiting

8

Centre Léon Bérard

Lyon, France

Actively Recruiting

9

Hopital Saint Joseph

Paris, France

Not Yet Recruiting

10

CHU Poitiers

Poitiers, France

Not Yet Recruiting

11

CHU Reims

Reims, France

Not Yet Recruiting

12

CH Yves Le foll

Saint-Brieuc, France

Actively Recruiting

13

CHU St Etienne

Saint-Etienne, France

Actively Recruiting

14

IUCT Toulouse

Toulouse, France

Not Yet Recruiting

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Research Team

C

CHEVALLIER Arthur

CONTACT

A

Anne VISBECQ

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

1

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