NMOSDCopilot App for Neuromyelitis Optica

(OPTIS Trial)

Recruiting at 20 trial locations

Overseen By Dr Levy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ad scientiam

Must be taking: NMOSD treatment

Disqualifiers: Neurologic, Rheumatologic, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

103 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that your NMOSD treatment has not changed in the last 6 months, and analgesics, antidepressants, and neuroleptics have not changed in the last month.

How is the NMOSDCopilot app treatment for neuromyelitis optica different from other treatments?

The NMOSDCopilot app is unique because it is a smartphone application designed to assist in managing neuromyelitis optica, unlike traditional treatments that focus on medication or physical interventions. This app may provide a novel way to track symptoms, manage treatment plans, and offer educational resources, which is different from standard drug therapies. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to read language in which the mobile application is available and understand pictograms

Able to use a smartphone

My condition has been stable for the last 3 months.

Exclusion Criteria

I do not have major neurological, mental health issues, or severe injuries affecting my brain or limbs.

I am under legal guardianship or curatorship.

Pregnant and nursing women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial in-clinic assessment and performance of digital tests and standard tests

1 day

1 visit (in-person)

At-home Self-assessment

Participants use the NMOSDCopilot application for unsupervised self-assessment of symptoms

12 months

Remote monitoring

In-clinic Follow-up Assessments

In-clinic assessments to compare with at-home results and evaluate safety, usability, and satisfaction

21 months

Visits at month 3, month 6, month 12

Follow-up

Participants are monitored for safety and effectiveness after the main assessment period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NMOSDCopilot smartphone application

Trial Overview 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.

How Is the Trial Designed?

Group I: NMOSDCopilot Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Ad scientiam

Lead Sponsor

Trials

12

Recruited

1,500+

Published Research Related to This Trial

Neuromyelitis optica spectrum disorders (NMOSD) related optic neuritis (NMOSD-ON) can lead to permanent blindness and is characterized by a high rate of recurrence and poor prognosis, highlighting the need for effective treatment strategies.

Recent advancements in understanding the pathogenesis of NMOSD have led to the development of new therapeutic approaches aimed at both treating acute attacks and preventing relapses, offering hope for improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in the treatment of neuromyelitis optica spectrum disorders related optic neuritis]. Song, HL., Xu, QG., Wei, SH.[2020]

The CIRCLES study has successfully enrolled over 1,000 participants with neuromyelitis optica spectrum disorder (NMOSD), providing a valuable resource for understanding the disease's epidemiology and treatment, with 77.5% of cases still actively followed up.

Key findings from the study indicate that the majority of active NMOSD cases are female (84%) and anti-AQP4 seropositive (76%), with a median age of onset at 38.4 years and an annualized relapse rate of 0.5, highlighting demographic patterns that could inform future research and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative International Research in Clinical and Longitudinal Experience Study in NMOSD. Cook, LJ., Rose, JW., Alvey, JS., et al.[2023]

A systematic review of 19 studies identified 410 cases of neuromyelitis optica spectrum disorder (NMOSD) in Africa, revealing a mean age of diagnosis at 33 years and a predominance of female patients (75%).

The most common symptoms at presentation were transverse myelitis and optic neuritis, with treatment primarily involving IV methylprednisolone for relapses and azathioprine for maintenance, highlighting the need for better data collection and healthcare access for NMOSD in Africa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromyelitis Optica Spectrum Disorders in Africa: A Systematic Review. Musubire, AK., Derdelinckx, J., Reynders, T., et al.[2023]

The N-MOmentum trial is investigating the safety and efficacy of MEDI-551, an anti-CD19 monoclonal antibody, in patients with neuromyelitis optica spectrum disorder (NMOSD), with a focus on minimizing patient exposure to placebo over a treatment period of up to 197 days.

This trial employs innovative statistical methods and interim analyses to ensure robust results while addressing the unique challenges of NMOSD clinical trials, aiming to accurately assess treatment effects and reduce risks for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical Considerations for an Adaptive Design for a Serious Rare Disease. Patra, K., Cree, BAC., Katz, E., et al.[2020]

The Brazilian Neuromyelitis Optica Database System (NMO-DBr) is a comprehensive database that collects and analyzes data from patients with neuromyelitis optica (NMO) and related disorders, enhancing the consistency of medical practice and research.

NMO-DBr includes detailed patient information such as symptoms, MRI results, and treatment history, while ensuring confidentiality and enabling statistical analysis, which can improve understanding and management of NMO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NMO-DBr: the Brazilian Neuromyelitis Optica Database System. Lana-Peixoto, MA., Talim, LE., Faria-Campos, AC., et al.[2019]

Citations

1. China pubmed.ncbi.nlm.nih.gov

[Progress in the treatment of neuromyelitis optica spectrum disorders related optic neuritis]. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Collaborative International Research in Clinical and Longitudinal Experience Study in NMOSD. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Neuromyelitis Optica Spectrum Disorders in Africa: A Systematic Review. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Statistical Considerations for an Adaptive Design for a Serious Rare Disease. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

NMO-DBr: the Brazilian Neuromyelitis Optica Database System. [2019]