OP2C : Prialt® Observatory in Clinical Practice

Study Overview
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Brief Summary
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Ziconotide (Prialt®) is a powerful analgesic, approved in Europe since 2005, and reserved for the intrathecal route. Ziconotide is a protein of 2500 Daltons isolated from a cone-snail: Conus Magus, acting by blocking the N-type voltage-sensitive calcium channels. Its efficacy has been proven by 3 randomized clinical trials. It is particularly effective on chronic refractory 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 became evident, especially neuropsychiatric reactions, which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment. 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 in different settings of patients with severe chronic pain requiring intrathecal analgesia.

Official Title
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OP2C : Prialt® Observatory in Clinical Practice

Conditions
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Refractory Pain

Intervention / Treatment
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* Drug: Ziconotide Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ziconotide Injection|Intrathecal analgesia with Ziconotide|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the tolerability to intrathecal ziconotide treatment | Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit | 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 | 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. | 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. | 7 years | 
| Responders profile detection | Responders profile according to efficacy on pain of intrathecal ziconotide treatment | 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 | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrathecal analgesia, Ziconotide