Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 8:11 PM
Study NCT ID:
NCT04321408
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OP2C : Prialt® Observatory in Clinical Practice
Sponsor:
Institut Cancerologie de l'Ouest
Organization:
Study Overview
Official Title:
OP2C : Prialt® Observatory in Clinical Practice
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OP2C
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: