Refractory Pain
Conditions
Keywords
Intrathecal analgesia, Ziconotide
Brief summary
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.
Interventions
DRUGZiconotide Injection
Intrathecal analgesia with Ziconotide
Sponsors
Esteve
Institut Cancerologie de l'Ouest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Severe refractory chronic pain requiring intrathecal analgesia * Candidate for intrathecal analgesia treatment with ziconotide * Patient informed about the study and agreeing to take part in.
Exclusion criteria
* Contraindications to ziconotide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 7 years | Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the efficacy on pain of intrathecal ziconotide treatment | 7 years | 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 |
| Estimate the duration of treatment according to the indication | 7 years | Time between the first and last date of administration of intrathecal ziconotide during study. |
| Describe the tolerability to intrathecal ziconotide treatment | 7 years | Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit |
| Responders profile detection | 7 years | Responders profile according to efficacy on pain of intrathecal ziconotide treatment |
| Describe quality of life under ziconotide treatment | 7 years | 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 |
| Subgroup comparative analysis | 7 years | Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability. |
Countries
France, Germany, Spain
Contacts
Primary ContactDENIS DUPOIRON, MD
Backup ContactMARINE TIGREAT
Outcome results
None listed