What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta-1a, fingolimod, and glatiramer acetate. Interferon beta-1a can cause flu-like symptoms, injection site reactions, liver enzyme abnormalities, and depression. Fingolimod is associated with headaches, elevated liver enzymes, diarrhea, cough, flu-like symptoms, and more serious risks such as bradyarrhythmia, macular edema, and increased susceptibility to infections. Glatiramer acetate may cause injection site reactions, lipoatrophy, and rarely, hepatotoxicity. These side effects are important considerations for patients and healthcare providers when choosing an appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies (DMTs) for the treatment of Multiple Sclerosis (MS). Interferon beta-1a, available in intramuscular and subcutaneous formulations, has been shown to reduce relapse rates and MRI lesion volumes. Fingolimod, an oral medication, has demonstrated long-term efficacy in reducing relapse rates and MRI lesion volumes, though it is associated with specific risks such as macular edema and infections. Other notable treatments include natalizumab, which has shown significant efficacy in reducing relapse rates and improving quality of life, and siponimod, which is effective in secondary progressive MS. These treatments are part of a broader strategy to manage MS, which includes monitoring disease progression through tools like the MSCopilot® Detect app.

What other types of research exist?

Promising alternatives to MSCopilot® Detect for remote monitoring and early detection of disease progression in MS patients include the use of passive biosensor measurement techniques, which have demonstrated feasibility in monitoring disability both in clinical and free-living settings. Additionally, telemedicine platforms that incorporate validated digital tests and questionnaires for symptom tracking and quality of life assessments are also emerging as effective tools. These methods leverage non-invasive digital technologies to provide continuous and accurate monitoring of MS progression.

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Behavioural Intervention

MSCopilot® App for Multiple Sclerosis (MS-DETECT 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 at home (day 1, month 6+1 day, month 12 + 1 day, month 18-1 day and month 24-1 day (if applicable)) and in-clinic ((day 0, month 6, month 12, month 18 and month 24 (if applicable))

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing MSCopilot® Detect, a smartphone app that helps people with Multiple Sclerosis (MS) monitor their condition from home. The app aims to make it easier to track disease progression and improve patient care. It involves 314 MS patients from several countries who will use the app to complete periodic questionnaires and tests. MSCopilot is a software medical device designed for the self-assessment of people with Multiple Sclerosis (PwMS), validated against traditional tests.

Who is the study for?

This trial is for adults aged 30-65 living with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis, who've been stable for the last 3 months and have an EDSS score of 2.5 to 6.5. Participants must own a smartphone compatible with the MSCopilot® Detect app, be able to use it effectively, and not be pregnant or nursing.

What is being tested?

The study tests MSCopilot® Detect, a mobile app designed for MS patients to monitor their disease progression at home. It aims to standardize remote monitoring by assessing changes in symptoms and predicting shifts in disability status through digital questionnaires and tests.

What are the potential side effects?

Since this trial involves using a smartphone application rather than medication, traditional side effects are not expected. However, users may experience issues related to usability such as eye strain or stress from regular self-monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at home (day 1, month 6+1 day, month 12 + 1 day, month 18-1 day and month 24-1 day (if applicable)) and in-clinic ((day 0, month 6, month 12, month 18 and month 24 (if applicable))

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at home (day 1, month 6+1 day, month 12 + 1 day, month 18-1 day and month 24-1 day (if applicable)) and in-clinic ((day 0, month 6, month 12, month 18 and month 24 (if applicable))

This trial's timeline: 3 weeks for screening, Varies for treatment, and at home (day 1, month 6+1 day, month 12 + 1 day, month 18-1 day and month 24-1 day (if applicable)) and in-clinic ((day 0, month 6, month 12, month 18 and month 24 (if applicable)) 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 evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.

Secondary study objectives

To assess reliability of MSCopilot® Detect individual scores and/or composite scores at-home over time.

To assess reproducibility of MSCopilot® Detect individual scores and/or composite scores between in-clinic and at-home digital tests.

To assess the satisfaction and user experience with the MSCopilot® Detect smartphone application and the MSCopilot® Detect web dashboard.

+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: MSCopilot® DetectExperimental Treatment1 Intervention

Performance of digital tests and standard test in clinic at D0, M6, M12, M18 and M24 (if applicable) Use of MSCopilot® Detect at-home in between visits during 18 or 24 months (if applicable)

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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

Common treatments for Multiple Sclerosis (MS) include beta interferons, glatiramer acetate, and oral agents like dimethyl fumarate and fingolimod. Beta interferons work by modulating the immune response to reduce inflammation and the frequency of relapses. Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Dimethyl fumarate activates the Nrf2 pathway, providing anti-inflammatory and neuroprotective effects. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the central nervous system. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, which is essential for maintaining quality of life and functional abilities.

Ocular motor signatures of cognitive dysfunction in multiple sclerosis.Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.