Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373211
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Early Immunotherapy With Intravenous Immunoglobulin Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Early Immunotherapy With Intravenous Immunoglobulin Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
NESPA
Brief Summary:
Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer Despite their autoimmune origin they have historically shown little response to immunotherapy The reason for this failure is probably related to too late administration of immunotherapy at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred The protocol focuses on patients with anti-Hu antibody sensory neuronopathy This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin IVIG for 3 months cyclophosphamide and methylprednisolone for 6 months at the rate of 1 cycle per month The percentage of patients with clinical improvement will be evaluated ONLS at 3 months The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506942-22-01 | OTHER | CTIS | None |