An observational study in Refractory Pain, sponsored by Institut Cancerologie de l'Ouest. Recruiting at 17 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Institut Cancerologie de l'Ouest · Observational
Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies.
It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis.
However, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration).
In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options.
However, there is a lack of data on the current use of ziconotide in current practice.
The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's planned enrollment of 300 is above the median of 91 across 19 observational studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →Institut Cancerologie de l'Ouest is the lead sponsor of 109 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intrathecal analgesia with Ziconotide
Also known as: Prialt
Describe the practical methods of using intrathecal treatments containing ziconotide: indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment, efficacy and safety in the real clinical practice and monitoring.
Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.
Time frame: 7 years
Describe the tolerability to intrathecal ziconotide treatment
Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit
Time frame: 7 years
Describe the efficacy on pain of intrathecal ziconotide treatment
The efficacy of the analgesic treatment is measured based on the numeric pain rating scale (0 to 10) at start of Ziconotide, 1, 3, 6, 12 months, and every 12 months thereafter
Time frame: 7 years
Estimate the duration of treatment according to the indication
Time between the first and last date of administration of intrathecal ziconotide during study.
Time frame: 7 years
Subgroup comparative analysis
Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability.
Time frame: 7 years
Responders profile detection
Responders profile according to efficacy on pain of intrathecal ziconotide treatment
Time frame: 7 years
Describe quality of life under ziconotide treatment
f) The Quality of life will be assessed by EQ5D-5L questionnaires under intrathecal ziconotide treatment, at 1, 3, 6, 12 months, and every 12 months thereafter until the registry remains open
Time frame: 7 years
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Plan to share: No
Started Jul 2020 (actual). Primary completion is estimated for Sep 2027, 86 months after the start.
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