Multiple SclerosisMS-DETECTNCT05816122
MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
A study testing MSCopilot® Detect mobile application in people with Multiple Sclerosis, run by Ad scientiam at 34 sites in 7 countries.
Trial summary
The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MSCopilot® Detect mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 34 sitesin 7 countries
- Study dates
- 22 Sep 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients living with RRMS or SPMS, aged 30 to 65
- EDSS score between 2.5 to 6.5 points
- With a disease duration > 5 years
- Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
- No change in the DMT* during the last 3 months before inclusion
- Receiving optimal symptomatic treatments at baseline (clinician's judgment)
Show all 10Show fewer
- Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion
- Able to use a smartphone
- Able to read language in wich the mobile application is available and able to understand pictograms.
- Applicable to patients enrolled in France only: affiliated to a social security system.
Who cannot join
- Medically unstable conditions that may hinder patient's ability to comply with the study procedures
- Inability to use a smartphone or MSCopilot® Detect application
- Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
- Pregnancy and nursing women
- Persons under guardianship or curatorship
- 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.
Trial locations and contacts
34 sites in 7 countries.
34 sites in 7 countries
United States10 sites
Joash Lazarus Sr.
Atlanta, Georgia, 30327
Leorah Freeman
Austin, Texas, 78712
Aaron Boster
Columbus, Ohio, 43235
Craig E. Herrman
Indianapolis, Indiana, 46256
Jennifer Feng
New Orleans, Louisiana, 70121
Daniel Wynn
Northbrook, Illinois, 60062
Gabriel Pardo
Oklahoma City, Oklahoma, 73104
Vijayshree Yadav
Portland, Oregon, 97239-3098
Jennifer Graves
San Diego, California, 92093
Robert Naismith
St Louis, Missouri, 63110
Spain6 sites
Gary Álvarez Bravo
Girona
Enric Monreal
Madrid
University Hospital San Carlos
Madrid
Ana Alonso
Málaga
Miguel Llaneza
Oviedo
Jesùs Martin
Zaragoza
France5 sites
Hôpital Roger Salengro
Lille
Cécile Donzé
Lomme
Adil Maarouf
Marseille
Mikael Cohen
Nice
Bertrand Bourre
Rouen
Canada4 sites
Galina Vorobeychik
Burnaby
Mark Freedman
Ottawa
St. Michael's Hospital
Toronto
Robert Carruthers
Vancouver
Denmark3 sites
University Hospital of Southern Denmark
Esbjerg
Finn Sellebjerg
Glostrup Municipality
Sivagini Prakash
Viborg
Germany3 sites
Boris-Alexander Kallman
Bayreuth
Universitätsklinikum Carl Gustav Carus
Dresden
Rupert Knoblich
Erbach im Odenwald
Italy3 sites
Emilio Portaccio
Florence
Emanuele D'Amico
Foggia
IRCCS Ospedale San Raffaele
Milan
About this study
The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).
The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.
Read more
A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.
Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).
Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.
The study will include 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France
- Conditions
- Multiple Sclerosis
- Being tested
- MSCopilot® Detect mobile application
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCopilot® Detect mobile applicationDevice
MSCopilot® Detect includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Multiple Sclerosis quality of life
| Study group | Role | What they receive |
|---|---|---|
| MSCopilot® Detect | Experimental | 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) Receives: Device: MSCopilot® Detect mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.
The discriminatory ability of the MSCopilot® Detect application in detecting clinically meaningful worsening (disability worsening) based on the revised-MSFC will be evaluated using the Area Under the ROC Curve (AUC) method. Confidence intervals will also be estimated.
The minimum significant AUC value will be set at >0.67, and Confidence Intervals will be calculated. Sensitivity and specificity will also be determined. To validate the estimated AUC values and cutoffs generated by the MSCopilot® Detect application, a train/test set will be utilised.
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
Secondary outcomes (14)
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on EDSS.
The study will evaluate the sensitivity, specificity, concordance, and accuracy of the MSCopilot® Detect application in predicting confirmed disability worsening (CDW) at 24 weeks as also captured by the EDSS, using a contingency table.
We will also generate time series box plots of MSCopilot® Detect individual scores and/or composite scores based on the patient progression status (determined by EDSS), using both intra-patient and inter-patient visualisation.
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening earlier than the EDSS.
The time to progression-free events based on EDSS and MSCopilot® Detect individual scores and/or composite scores will be estimated with a Kaplan-Meier method (Log-rank test for comparison). Univariate and multivariate survival models (e.g. Cox or Anderson-Gill survival model), will be used to estimate Hazards Rates (HRs), if relevant.
Proportions of disability worsening based on MSCopilot® Detect composite or individual scores and worsening based on the EDSS 24-week CDW will be compared for each timepoint.
Time series boxplot of MSCopilot® Detect individual scores and/or composite score according to the patient disability worsening (by EDSS) intra-patient and inter-patient.
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect individual and/or composite scores ability to detect disease progression in absence of a relapsing activity (PIRA).
Proportion of patients with PIRA (progression independent of relapses) based either on EDSS 24-week CDP compared to the proportion of patients with PIRA based on MSCopilot® Detect composite or individual scores progression status.
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect individual scores and/or composite scores ability to detect MSFC changes over time.
Slopes parameters will be computed using a mix model to characterize the change from baseline in MSCopilot® Detect individual and/or composite scores and revised-MSFC scores over time.
The association between these slopes parameters will be assessed using correlation coefficient.
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To measure MSCopilot® Detect individual scores and/or composite scores association with the clinical scores.
The association between digital and clinical scores will be studied with correlation coefficient calculated between:
- MSCopilot® Detect individual scores ((MWPT, MDT, MCT, MVT and Mobile Walking Endurance Test (MWET)) and/or composite score at home and EDSS score performed in clinic.
- MSCopilot® Detect individual scores (MWPT, MDT, MCT, MVT and MWET) and/or composite score at home and revised-MSFC-3 or Revised-MSFC3 + SLCLAT scores performed in clinic.
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To assess reproducibility of MSCopilot® Detect individual scores and/or composite scores between in-clinic and at-home digital tests.
Intraclass correlation coefficient (ICC) between MSCopilot® Detect individual scores and/or composite score at home and in-clinic.
Measured: 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))
To assess reliability of MSCopilot® Detect individual scores and/or composite scores at-home over time.
Intraclass correlation coefficient (ICC) of MSCopilot® Detect individual scores and/or composite score at home with a maximum paired time point of 6 months.
ICC of MSCopilot® Detect individual scores and/or composite score at home will over time.
Measured: Day 0 versus Month 6, Month 6 versus Month 12, Month 12 versus Month 18, Month18 versus Month 24 (if applicable) AND Day 0 to Month 18 or Day 0 to Month 24 (if applicable) and Day 0 to Month 15 or Day 0 to Month 21 (if applicable) at home.
To evaluate Patient QoL (Multiple Sclerosis Impact Scale: MSIS-29 and Modified Fatigue Impact Scale - 5-item version: MFIS-5) and their association with MSCopilot® Detect individual and composite scores.
Analysis of MSIS-29 and MFIS-5 questionnaires:
Descriptive analysis of questionnaire scores over time. Comparison of Patient QoL between patients with and without a confirmed disability worsening Correlation between MSCopilot® Detect individual and/or composite score at home and Questionnaires scores (MSIS29 and MFIS-5).
Sensitivity, specificity, concordance, and accuracy will be evaluated between clinically meaningful change of MSCopilot® Detect application (individual and composite scores) and questionnaires (MSIS29 and MFIS-5).
Proportions comparison of patients with a clinically meaningful change will be assessed between MSCopilot® Detect application (individual and composite scores) and questionnaires (MSIS29 and MFIS-5).
Clinically meaningful change for questionnaires:
MSIS-29: 8-point change compared to baseline. MFIS-5: 4-point change compared to baseline.
Measured: Throughout the study between in clinic visit, an average of 24 months
To evaluate the ability of MSCopilot® Detect individual scores and/or composite score to discriminate between a relapse and a momentary disability worsening (+1 point EDSS score for an initial EDSS <5,5; +0.5 point for an initial EDSS ≥5.5).
Descriptive analysis:
MSCopilot® Detect individual and/or composite score profiles, between relapse and a momentary disability worsening patient.
Annualized Relapse Rate (ARR) calculation. Logistic regression to estimate Area under ROC Curve (i.e. discriminatory power).
Measured: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect Safety
Descriptive analysis of the number of Adverse Events related to MSCopilot® Detect will be reported.
Measured: Throughout the study between in clinic visit, an average of 24 months
To evaluate MSCopilot® Detect Adherence
Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of performed tests, number of performed sessions, etc.)
Measured: Throughout the study between in clinic visit, an average of 24 months
To assess the satisfaction and user experience with the MSCopilot® Detect smartphone application and the MSCopilot® Detect web dashboard.
Descriptive analysis over the course of the study of the answers to the patient satisfaction and user experience questionnaires related to the use of the MSCopilot® Detect smartphone application.
Measured: Every 3 months for about 24 months
To assess the satisfaction and user experience with the MSCopilot® Detect web dashboard.
Descriptive analysis over the course of the study of the answers to physician satisfaction \& user experience questionnaires relative to the use of the MSCopilot® Detect web dashboard.
Measured: Every 6 months for about 24 months
To describe the evolution of MSCopilot® Detect individual scores and/or composite scores at-home over time.
The time to progression-free events based on MSCopilot® Detect individual scores and/or composite scores will be estimated with a Kaplan-Meier method (Log-rank test for comparison). Univariate and multivariate survival models (e.g. Cox or Anderson-Gill survival model), will be used to estimate Hazards Rates (HRs), if relevant.
Cumulative proportions of disability worsening based on MSCopilot® Detect composite or individual scores for each timepoint.
Time series boxplot of MSCopilot® Detect individual scores and/or composite score according to the patient disability worsening (by MSCopilot® Detect) using both intra-patient and inter-patient visualisation.
Measured: Throughout the study between in clinic visit, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start22 Sep 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816122
- Sponsor's protocol ID
- MS-DETECT
- Acronym
- MS-DETECT
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
- ClinicalTrials.gov ID
- NCT05816122
- Acronym / sponsor ID
- MS-DETECT / MS-DETECT
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).
The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.
A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.
Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).
Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.
The study will include 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCopilot® Detect | Experimental | Device: MSCopilot® Detect mobile applicationPerformance 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) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients living with RRMS or SPMS, aged 30 to 65
- EDSS score between 2.5 to 6.5 points
- With a disease duration > 5 years
- Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
- No change in the DMT* during the last 3 months before inclusion
Key exclusion criteria (7 listed)
- Medically unstable conditions that may hinder patient's ability to comply with the study procedures
- Inability to use a smartphone or MSCopilot® Detect application
- Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
- Pregnancy and nursing women
- Persons under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCopilot® Detect mobile applicationMSCopilot® Detect includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Multiple Sclerosis quality of life | Device | MSCopilot® Detect |
Primary outcome
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
The discriminatory ability of the MSCopilot® Detect application in detecting clinically meaningful worsening (disability worsening) based on the revised-MSFC will be evaluated using the Area Under the ROC Curve (AUC) method. Confidence intervals will also be estimated. The minimum significant AUC value will be set at >0.67, and Confidence Intervals will be calculated. Sensitivity and specificity will also be determined. To validate the estimated AUC values and cutoffs generated by the MSCopilot® Detect application, a train/test set will be utilised.
14 secondary outcomes
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on EDSS.
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening earlier than the EDSS.
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect individual and/or composite scores ability to detect disease progression in absence of a relapsing activity (PIRA).
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect individual scores and/or composite scores ability to detect MSFC changes over time.
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To measure MSCopilot® Detect individual scores and/or composite scores association with the clinical scores.
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To assess reproducibility of MSCopilot® Detect individual scores and/or composite scores between in-clinic and at-home digital tests.
Time frame: 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))
To assess reliability of MSCopilot® Detect individual scores and/or composite scores at-home over time.
Time frame: Day 0 versus Month 6, Month 6 versus Month 12, Month 12 versus Month 18, Month18 versus Month 24 (if applicable) AND Day 0 to Month 18 or Day 0 to Month 24 (if applicable) and Day 0 to Month 15 or Day 0 to Month 21 (if applicable) at home.
To evaluate Patient QoL (Multiple Sclerosis Impact Scale: MSIS-29 and Modified Fatigue Impact Scale - 5-item version: MFIS-5) and their association with MSCopilot® Detect individual and composite scores.
Time frame: Throughout the study between in clinic visit, an average of 24 months
To evaluate the ability of MSCopilot® Detect individual scores and/or composite score to discriminate between a relapse and a momentary disability worsening (+1 point EDSS score for an initial EDSS <5,5; +0.5 point for an initial EDSS ≥5.5).
Time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
To evaluate MSCopilot® Detect Safety
Time frame: Throughout the study between in clinic visit, an average of 24 months
To evaluate MSCopilot® Detect Adherence
Time frame: Throughout the study between in clinic visit, an average of 24 months
To assess the satisfaction and user experience with the MSCopilot® Detect smartphone application and the MSCopilot® Detect web dashboard.
Time frame: Every 3 months for about 24 months
To assess the satisfaction and user experience with the MSCopilot® Detect web dashboard.
Time frame: Every 6 months for about 24 months
To describe the evolution of MSCopilot® Detect individual scores and/or composite scores at-home over time.
Time frame: Throughout the study between in clinic visit, an average of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSCopilot® Detect mobile application in people with Multiple Sclerosis, run by Ad scientiam at 34 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Spain, France, Canada, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores. (time frame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025; AzTrials last refreshed its copy on 3 Nov 2026.