Clinical trial · Observational
Ziconotide for Non-cancer Pain by Intrathecal Administration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ziconotide [Prialt] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated by ziconotide-based intrathecal analgesia (ITA)
- description
- Patients followed during 2 years after an initiation of ziconotide. These patients will be recruited retrospectively or prospectively.
- interventionNames
- Drug: Ziconotide [Prialt]
Primary outcomes (11)
- measure
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics
- timeFrame
- Baseline (treatment initiation)
- description
- Patient's demographic characteristics
- measure
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
- timeFrame
- Baseline (treatment initiation)
- description
- Relevant medical history, including history of psychiatric disorders
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available