Ziconotide for Non-cancer Pain by Intrathecal Administration

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Clinique de la Casamance
RECRUITING
Aubagne
Hospices Civils de Lyon
RECRUITING
Bron
Polyclinique du Parc
NOT_YET_RECRUITING
Caen
CHD Vendée
RECRUITING
La Roche-sur-yon
CH Laon
RECRUITING
Laon
CHU Lille
RECRUITING
Lille
Clinique Mutualiste de la Porte de l'Orient
RECRUITING
Lorient
Centre Léon Bérard
RECRUITING
Lyon
Hopital Saint Joseph
NOT_YET_RECRUITING
Paris
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Reims
NOT_YET_RECRUITING
Reims
CH Yves Le foll
RECRUITING
Saint-brieuc
CHU St Etienne
RECRUITING
Saint-etienne
IUCT Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
CHEVALLIER Arthur
achevallier@esteve.com
+33 (0)7 84 15 86 75
Backup
Anne VISBECQ
anne.visbecq@yahoo.fr
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2029-10-30
Participants
Target number of participants: 85
Treatments
Patients treated by ziconotide-based intrathecal analgesia (ITA)
Patients followed during 2 years after an initiation of ziconotide. These patients will be recruited retrospectively or prospectively.
Sponsors
Leads: ESTEVE Pharmaceuticals SAS

This content was sourced from clinicaltrials.gov