Clinical Trial: Neuromyelitis Optica (NMO) & Cetirizine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica

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 h

Detailed Summary:

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.

Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome:

• Annualized relapse rate before cetirizine [ Time Frame: Baseline ]
• Annualized relapse rate after cetirizine [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Epworth Sleepiness Scale [ Time Frame: Baseline ]
  Sedation as measured by Epworth Sleepiness Scale. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score 0 to 24 from unlikelihood of abnormally sleep to excessively sleepy.
• Epworth Sleepiness Scale [ Time Frame: 3 months ]
  Sedation as measured by Epworth Sleepiness Scale
• Epworth Sleepiness Scale [ Time Frame: 6 months ]
  Sedation as measured by Epworth Sleepiness Scale
• Epworth Sleepiness Scale [ Time Frame: 1 year ]
  Sedation as measured by Epworth Sleepiness Scale
• Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline ]
  Disability as measured by Expanded Disability Status Scale (EDSS). The EDSS provides a total score on a scale from 0 to 10, from normal function to lessening function with higher score, with 10 being death due to MS.
• EDSS [ Time Frame: 1 year ]
  Disability as measured by Expanded Disability Status Scale (EDSS)
• Eosinophil counts in the blood [ Time Frame: Baseline ]
  Immunological measures related to eosinophil activity
• Eosinophil counts in the blood [ Time Frame: 3 months ]
  Immunological measures related to eosinophil activity
• Eosinophil counts in the blood [ Time Frame: 6 months ]
  Immunological measures related to eosinophil activity

Original Secondary Outcome: Same as current

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: August 9, 2016
Date Started: April 2014
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016