Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541184
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Ziconotide for Non-cancer Pain by Intrathecal Administration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ziconotide for Non-cancer Pain by Intrathecal Administration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although ziconotides marketing authorization does not restrict its use to a given type of pain the drug has been used mainly in cancer patients Most data on ziconotide-based intrathecal IT treatment has therefore been obtained in this population for whom the drugs place is clearly documented national and international recommendations
In contrast the management of non-cancer pain is less straightforward partly because of the very large range of possible clinical conditions and the utilization of ziconotide is poorly documented mainly described in single-centre small series
Due to the lack of data physicians are often reluctant to undertake this type of treatment which may represent a loss of opportunity for patients
This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy treated by ziconotide-based intrathecal analgesia
Patients suffering from all types of non-malignant pain will be eligible for the study including but not limited to spinal cord injury radiculopathy failed back surgery diabetic neuropathy central pain syndrome complex regional pain syndrome chemotherapy-induced neuropathy fibromyalgia
The collected data will cover the first 2 years of treatment
In contrast the management of non-cancer pain is less straightforward partly because of the very large range of possible clinical conditions and the utilization of ziconotide is poorly documented mainly described in single-centre small series
Due to the lack of data physicians are often reluctant to undertake this type of treatment which may represent a loss of opportunity for patients
This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy treated by ziconotide-based intrathecal analgesia
Patients suffering from all types of non-malignant pain will be eligible for the study including but not limited to spinal cord injury radiculopathy failed back surgery diabetic neuropathy central pain syndrome complex regional pain syndrome chemotherapy-induced neuropathy fibromyalgia
The collected data will cover the first 2 years of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None