Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02865018
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2016-08-09
Brief Title:
Neuromyelitis Optica NMO Cetirizine
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
An Open Label add-on Trial of Cetirizine for Patients With Neuromyelitis Optica
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
Neuromyelitis optica NMO is an autoimmune disease that affects the central nervous system Patients have relapses also known as attacks which are often quite severe and leave them with significant disability Without treatment within 5 years 50 of NMO patients are blind in one or both eyes or require walking assistance cane walker or wheelchair
NMO has only been relatively recently described and is fairly rare Most NMO patients immune systems produce abnormal antibodies against aquaporin-4 AQP4 which is found in certain cells in the central nervous system When these AQP4 antibodies bind to AQP4 they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system This ultimately leads to disability some of which is permanent
Until now treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody However recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell Specifically researchers have noted the importance of a specific cell type eosinophils in causing damage in NMO lesions In a recent study researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine which is a popular over-the-counter allergy medicine
Cetirizine is already known to be safe and well-tolerated in the general population In this study the researchers plan to add cetirizine on to patients current NMO treatment The researchers aim to show that it is safe well-tolerated and that with cetirizine NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid
NMO has only been relatively recently described and is fairly rare Most NMO patients immune systems produce abnormal antibodies against aquaporin-4 AQP4 which is found in certain cells in the central nervous system When these AQP4 antibodies bind to AQP4 they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system This ultimately leads to disability some of which is permanent
Until now treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody However recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell Specifically researchers have noted the importance of a specific cell type eosinophils in causing damage in NMO lesions In a recent study researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine which is a popular over-the-counter allergy medicine
Cetirizine is already known to be safe and well-tolerated in the general population In this study the researchers plan to add cetirizine on to patients current NMO treatment The researchers aim to show that it is safe well-tolerated and that with cetirizine NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid
Detailed Description:
The researchers hypothesize that cetirizine an allergy medication that acts as an eosinophil-stabilizer will decrease the relapse rate when added to current standard therapy in patients with neuromyelitis optica
Medication compliance will be assessed by the research coordinator at each visit through discussion with the patient and pill counting
Medication compliance will be assessed by the research coordinator at each visit through discussion with the patient and pill counting
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