NCT06541184 Ziconotide for Non-cancer Pain by Intrathecal Administration
| NCT ID | NCT06541184 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ESTEVE Pharmaceuticals SAS |
| Condition | Pain, Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2029-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 85 participants in total. It began in 2024-10-30 with a primary completion date of 2029-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06541184 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541184 currently recruiting?
Yes, NCT06541184 is actively recruiting participants. Contact the research team at achevallier@esteve.com for enrollment information.
Where is the NCT06541184 trial being conducted?
This trial is being conducted at Aubagne, France, Bron, France, Caen, France, La Roche-sur-Yon, France and 10 additional locations.
Who is sponsoring the NCT06541184 clinical trial?
NCT06541184 is sponsored by ESTEVE Pharmaceuticals SAS. The trial plans to enroll 85 participants.