Actively Recruiting
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
Eligibility Criteria
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
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
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
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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