NCT06541184

Ziconotide for Non-cancer Pain by Intrathecal Administration

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 85 (estimated)
• Sponsor: ESTEVE Pharmaceuticals SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Chronic

Interventions

Type	Name	Description
DRUG	Ziconotide [Prialt]	Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.

Timeline

• Start date: 2024-10-30
• Primary completion: 2029-10-30
• Completion: 2029-10-30
• First posted: 2024-08-07
• Last updated: 2025-02-27

Locations

14 sites across 1 country: France