What is the mechanism of action of this treatment?

The most common treatments for Neuromyelitis Optica (NMO) include immunosuppressive therapies such as azathioprine and mycophenolate mofetil, as well as monoclonal antibodies like rituximab. These treatments work by targeting and reducing the activity of the immune system, which is responsible for the inflammation and damage to the optic nerves and spinal cord in NMO. By suppressing the immune response, these therapies help to prevent relapses and reduce the severity of symptoms. This is crucial for NMO patients as it helps to maintain their neurological function and improve their quality of life. The NMOSDCopilot digital self-assessment tool aims to monitor these symptoms effectively, providing valuable data to healthcare providers to optimize treatment plans.

What side effects are associated with this type of intervention?

Common treatments for Neuromyelitis Optica (NMO) include immunosuppressive therapies such as rituximab, azathioprine, and mycophenolate mofetil. Rituximab can cause infusion reactions, infections, and low blood cell counts. Azathioprine may lead to gastrointestinal issues, liver toxicity, and increased risk of infections. Mycophenolate mofetil is associated with gastrointestinal disturbances, infections, and hematologic abnormalities. These treatments require careful monitoring to manage and mitigate potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuromyelitis Optica Spectrum Disorder (NMOSD), including eculizumab (Soliris), inebilizumab (Uplizna), and satralizumab (Enspryng). These treatments focus on reducing the frequency of relapses and managing symptoms. While the NMOSDCopilot is a digital tool for self-assessment and symptom monitoring, it complements these pharmacologic treatments by enabling patients to track their symptoms and share data with healthcare providers for better management of the disease.

What other types of research exist?

Promising novel alternatives to NMOSDCopilot for NMO patients in 2024 may include: 1) Digital health platforms integrating AI for personalized symptom tracking and predictive analytics. 2) Wearable devices that monitor physiological parameters and provide real-time data to healthcare providers. 3) Advanced telemedicine applications with integrated e-questionnaires and remote diagnostic tools. 4) Comprehensive patient management systems that combine digital self-assessment with virtual consultations and treatment adherence monitoring.

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Behavioural Intervention

NMOSDCopilot App for Neuromyelitis Optica (OPTIS Trial)

N/A

Recruiting

Research Sponsored by Ad scientiam

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1, month 2, month 3, month 4, month 5

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing NMOSDCopilot, a digital tool for NMOSD patients to self-assess symptoms at home using a smartphone app. The app includes tests and questionnaires, and doctors can monitor the results through a web portal. The study aims to validate the tool's accuracy, reliability, safety, and user satisfaction.

Who is the study for?

This trial is for adults aged 18-60 with Neuromyelitis Optica (NMO), specifically AQP4+ diagnosed by the 2015 criteria. Participants must be stable on treatment for at least 6 months, have an EDSS score of ≤7, and no relapses in the past 3 months. They need to own a compatible smartphone and understand the app's language.

What is being tested?

The NMOSDCopilot smartphone application is being tested for its ability to accurately assess NMO symptoms at home compared to standard in-clinic tests. The study will also evaluate safety, usability, and satisfaction with both patient app and healthcare professional web portal.

What are the potential side effects?

Since this trial involves a digital tool rather than medication or invasive procedures, traditional side effects are not expected. However, participants may experience frustration or fatigue from using the app if they find it difficult to navigate or use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1, month 2, month 3, month 4, month 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1, month 2, month 3, month 4, month 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1, month 2, month 3, month 4, month 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test

Secondary study objectives

To assess at-home compliance and adherence to the patient application

To assess bladder control

To assess bowel control

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NMOSDCopilotExperimental Treatment1 Intervention

Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neuromyelitis Optica (NMO) include immunosuppressive therapies such as azathioprine and mycophenolate mofetil, as well as monoclonal antibodies like rituximab. These treatments work by targeting and reducing the activity of the immune system, which is responsible for the inflammation and damage to the optic nerves and spinal cord in NMO. By suppressing the immune response, these therapies help to prevent relapses and reduce the severity of symptoms. This is crucial for NMO patients as it helps to maintain their neurological function and improve their quality of life. The NMOSDCopilot digital self-assessment tool aims to monitor these symptoms effectively, providing valuable data to healthcare providers to optimize treatment plans.