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Ziconotide for Non-cancer Pain by Intrathecal Administration
Sponsor: ESTEVE Pharmaceuticals SAS
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
85
Start Date
2024-10-30
Completion Date
2029-10-30
Last Updated
2025-02-27
Healthy Volunteers
No
Conditions
Interventions
Ziconotide [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