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.
Study Type
OBSERVATIONAL
Enrollment
300
Intrathecal analgesia with Ziconotide
Institut de Cancerologie de L'Ouest
Angers, France
ACTIVE_NOT_RECRUITINGCentre Hospitalier Departemental La Roche Sur Yon
La Roche-sur-Yon, France
ACTIVE_NOT_RECRUITINGCentre Leon Berard
Lyon, France
ACTIVE_NOT_RECRUITINGInstitut de Cancerologie de Montpellier
Montpellier, France
SUSPENDEDClinique Breteche
Nantes, France
SUSPENDEDCHU NICE
Nice, France
SUSPENDEDInstitut Curie
Saint-Cloud, France
SUSPENDEDHopital - Foch
Suresnes, France
ACTIVE_NOT_RECRUITINGUniversity of Freiburg
Freiburg im Breisgau, Germany
RECRUITINGJustus-Liebig-Universitat
Giessen, Germany
RECRUITING...and 7 more locations
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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