Ziconotide for Non-cancer Pain by Intrathecal Administration
RecruitingNCT06541184
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Ziconotide for Non-cancer Pain by Intrathecal Administration
- Conditions
- Interventions
- Drug: Ziconotide [Prialt]
- Sponsor
- ESTEVE Pharmaceuticals SAS
- Start date
- 2024-10-30
- Primary completion
- 2029-10-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 14
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age ≥18 years, 2. Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy, 3. Having received information on and not opposed to data collection, Inclusion criteria specific for the retrospective cohort: Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment Inclusion criteria specific for the prospective cohort: 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 Exclusion Criteria: 1. Contraindication to intrathecal therapy or to ziconotide 2. Any condition that may jeopardize appropriate follow-up of the treatment 3. Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06541184