MSCopilot® App for Multiple Sclerosis

(MS-DETECT Trial)

Not currently recruiting at 44 trial locations

Overseen By Gabriel Pardo, Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ad scientiam

Disqualifiers: Medically unstable, Visual acuity, Pregnancy, others

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

Approved in 8 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app designed to help people with Multiple Sclerosis (MS) track their symptoms from home. The goal is to simplify monitoring MS progression, whether due to relapses or gradual worsening, and to determine if the MSCopilot® mobile application can predict changes in disability levels. Participants will use the app to complete surveys and digital tests, aiming to detect any changes in their condition early. This trial suits adults with MS who have had the disease for more than 5 years, are stable without recent relapses, and are comfortable using a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve daily life for people with MS.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you must be clinically stable and not have changed your disease-modifying therapy (DMT) in the last 3 months before joining the study.

What prior data suggests that the MSCopilot® app is safe for monitoring MS patients?

Research has shown that the MSCopilot® app is designed for people with multiple sclerosis to help them monitor their condition at home. The app includes tests, such as a walking test, to assess MS symptoms. Although specific safety data for this app is not available, it is generally considered safe as it is a digital tool, not a drug or device that enters the body.

The app is part of a study evaluating its effectiveness in tracking disease progression and predicting changes in disability scores. As a smartphone app, it poses no direct physical risks. However, like any app, it relies on users to enter data accurately. For those considering participation in the study, the main focus is on how well the app aids in managing and understanding MS, with no known safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for multiple sclerosis, which often focus on managing symptoms through medications like interferons or monoclonal antibodies, the MSCopilot® app offers a unique digital approach. Researchers are excited because it allows patients to perform digital assessments at home, providing ongoing insights into their condition between clinic visits. This convenience and continuous monitoring could lead to more personalized and timely adjustments in treatment plans, potentially improving patient outcomes in a way that traditional in-clinic assessments can't match.

What evidence suggests that the MSCopilot® app is effective for monitoring Multiple Sclerosis?

Research has shown that the MSCopilot® app is a dependable tool for monitoring disability in people with Multiple Sclerosis (MS). Studies confirm that it integrates well into regular care routines and helps track MS symptoms such as walking, hand coordination, thinking, and vision. Early results suggest that mobile health apps, including MSCopilot®, can slightly to moderately improve thinking skills and reduce tiredness in MS patients. This trial's MSCopilot® Detect arm will specifically study the app's ability to detect early changes in the disease and predict how disability might progress. Overall, MSCopilot® appears to be a promising tool for managing MS. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 30 and 65 years old with relapsing-remitting or secondary progressive MS.

My disability level is moderate to severe but I can still walk.

My health has been stable for the last 3 months without any worsening.

Exclusion Criteria

Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)

Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study

Medically unstable conditions that may hinder patient's ability to comply with the study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inclusion

Participants download the MSCopilot® Detect app and complete an inclusion visit

1 day

1 visit (in-person)

Monitoring

Participants use the MSCopilot® Detect app for at-home monitoring and complete digital tests every 3 months

18-24 months

Digital tests every 3 months

Follow-up

Participants attend follow-up visits to assess disease progression and app usability

18-24 months

3-4 visits (in-person) at 6, 12, 18, and optionally 24 months

What Are the Treatments Tested in This Trial?

Interventions

• MSCopilot® mobile application

Trial Overview 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.

How Is the Trial Designed?

Group I: MSCopilot® Detect Experimental Treatment 1 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)

MSCopilot® mobile application is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as MSCopilot Detect for:

• Monitoring of Multiple Sclerosis progression

Approved in United States as MSCopilot Detect for:

• Monitoring of Multiple Sclerosis progression

Approved in Canada as MSCopilot Detect for:

• Monitoring of Multiple Sclerosis progression

Who Is Running the Clinical Trial?

Ad scientiam

Lead Sponsor

Trials

12

Recruited

1,500+

Published Research Related to This Trial

The PatientConcept mobile app, used by about 3000 MS patients since its launch in 2018, enhances communication between patients and physicians while allowing patients to track their health data securely and anonymously.

The app supports adherence to treatment plans by mapping risk management for disease-modifying therapies and enables continuous monitoring of Patient Reported Outcomes (PROs), making it a valuable tool for managing multiple sclerosis and potentially other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ID-Associated Application to Facilitate Patient-Tailored Management of Multiple Sclerosis. Lang, M., Rau, D., Cepek, L., et al.[2021]

The MSCopilot software demonstrated a strong correlation with the Expanded Disability Status Scale (EDSS) in assessing disability levels in 116 people with Multiple Sclerosis, indicating its reliability as a self-assessment tool.

MSCopilot was particularly effective in distinguishing between patients with higher disability levels (EDSS > 3.5), outperforming traditional MSFC tests by capturing nuances in different stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MSCopilot: New smartphone-based digital biomarkers correlate with Expanded Disability Status Scale scores in people with Multiple Sclerosis. Tanoh, IC., Maillart, E., Labauge, P., et al.[2021]

The smartphone-based Symbol Digit Modalities Test (sSDMT) demonstrated improved reproducibility in measuring cognitive function in 102 patients with multiple sclerosis, with a standard error of measurement of 2.94 and a smallest detectable change of 8.15, making it a reliable tool for monitoring cognitive impairment.

Using a local linear trend model on weekly sSDMT scores allows for detailed tracking of cognitive changes over time, enabling the detection of significant changes with assessments every 12 days, thus enhancing individualized patient monitoring in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards individualized monitoring of cognition in multiple sclerosis in the digital era: A one-year cohort study. Lam, KH., Bucur, IG., Van Oirschot, P., et al.[2022]

The 5 U-Turn Test (5UTT) demonstrated good-to-excellent test-retest reliability for measuring U-turn speed in people with multiple sclerosis (MS), with an intraclass correlation coefficient of 0.87, indicating it is a reliable tool for assessing gait and balance impairment.

U-turn speed from the 5UTT was significantly correlated with established in-clinic measures of walking speed and overall MS-related disability, suggesting that this smartphone-based assessment can effectively monitor mobility changes in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U-turn speed is a valid and reliable smartphone-based measure of multiple sclerosis-related gait and balance impairment. Cheng, WY., Bourke, AK., Lipsmeier, F., et al.[2021]

Mobile health applications (mHealth) show promise in improving cognitive function and reducing fatigue in people with multiple sclerosis, with a small effect size for cognitive training (SMD = 0.28) and a moderate effect for fatigue (SMD = 0.61) based on a review of 36 studies involving 3091 patients.

Despite the positive findings, the current level of evidence is still unclear, and more studies are needed to validate the efficacy of mHealth interventions across various functioning problems in multiple sclerosis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is mHealth a Useful Tool for Self-Assessment and Rehabilitation of People with Multiple Sclerosis? A Systematic Review. Bonnechère, B., Rintala, A., Spooren, A., et al.[2021]

A study is being conducted to test whether a mobile application can significantly increase the reporting of adverse drug reactions (ADRs) among patients with relapsing-remitting multiple sclerosis (RR-MS) who are using disease-modifying drugs (DMDs).

The trial aims to enroll 180 patients across 24 centers, with the expectation that the app will boost ADR reporting by ten times compared to traditional methods, highlighting the importance of patient involvement in monitoring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Defer, G., Le Caignec, F., Fedrizzi, S., et al.[2019]

Digital technology tools are increasingly being integrated into clinical trials for multiple sclerosis (MS), enhancing treatment delivery and disease monitoring through methods like psychotherapy apps and robot-assisted exercises.

These technologies improve the standardization of outcome measures and enable better detection of symptoms and treatment adherence, shifting data collection from traditional paper-based methods to more efficient internet-based systems, which can also facilitate remote rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. De Angelis, M., Lavorgna, L., Carotenuto, A., et al.[2021]

The MSCopilot software device was validated against the Multiple Sclerosis Functional Composite (MSFC) in a study involving 141 patients with multiple sclerosis (PwMS) and 76 healthy controls, showing that it is as effective as MSFC in identifying disability in PwMS.

MSCopilot demonstrated strong correlation with MSFC scores (r = 0.81) and good reproducibility, making it a reliable tool for self-assessment of MS-related disability in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MSCopilot, a new multiple sclerosis self-assessment digital solution: results of a comparative study versus standard tests. Maillart, E., Labauge, P., Cohen, M., et al.[2021]

The Optimise:MS study has recruited over 2,000 participants from 14 hospitals in the UK to assess the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in real-world settings, focusing on serious adverse events (SAEs).

The study's statistical analysis plan is designed to address complex confounding factors and will provide valuable insights into the long-term outcomes of DMTs, including the effects of treatment switching and pregnancy outcomes, which are often not covered in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. Waddingham, E., Miller, A., Dobson, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06922942

NCT06922942 | MSCopilot Users' Feedback in Real Life This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31538396/

MSCopilot, a new multiple sclerosis self-assessment digital ... This study confirms the reliability of MSCopilot and its usability in clinical practice for the monitoring of MS-related disability.

3. withpower.com withpower.com/trial/phase-multiple-sclerosis-5-2023-8f8ad

MSCopilot® App for Multiple Sclerosis (MS-DETECT Trial) Additionally, mobile health apps, like MSCopilot, have shown small to moderate benefits in improving cognitive function and reducing fatigue in MS patients.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05816122/ms-detect-early-detection-of-multiple-sclerosis-progression-with-mscopilotr-detect

MS-DETECT: Early Detection of Multiple Sclerosis ... The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).

5. mscopilot.com mscopilot.com/

MSCopilot The MSCopilot® application allows to conduct MS assessment tests through walking, dexterity, cognition and low-contrast vision exercises. To log into the ...

6. play.google.com play.google.com/store/apps/details?id=com.adscientiam.da100b&hl=en_US

MSCopilot® DETECT - Apps on Google Play MSCopilot Detect is an application dedicated to people with multiple sclerosis featuring the following tests: Walking perimeter test.

7. ctv.veeva.com ctv.veeva.com/study/ms-detect-early-detection-of-multiple-sclerosis-progression-with-mscopilot-r

Early Detection of Multiple Sclerosis Progression With ... The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).