Myasthenia Gravis, GeneralizedHARMONY 360NCT07323316
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
A study testing MyoSense 360 in people with Myasthenia Gravis, Generalized, run by Ad scientiam at 20 sites in 5 countries.
Trial summary
The purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Generalized
- What is being tested?
- MyoSense 360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 6 Oct 2026to Oct 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at screening
- Patients with gMG diagnosis confirmed by the investigator based at least on one of the following:
- Positive antibody testing for ACHR or MuSK antibodies; or,
- LRP-4 antibodies or seronegative patients with additional positive single fiber examination; or,
- Abnormal single-fiber EMG (SFEMG) jitter in at least one clinically weak muscle; or,
- Objective evidence of improvement of clinical gMG symptoms following treatment with oral AChEI or positive pyridostigmine or neostigmine or edrophonium test
Show all 12Show fewer
- MGFA Class IIa to IVb
- Having read the information sheet and signed the informed consent form
- Owning and able to use a personal smartphone which software version is above 16 for iOS and 8 for Android included
- Able to read languages in which the mobile application is available and able to understand pictograms (MyoSense 360 is available in local official languages)
- Able to use an activity monitor (per Actigraph LEAP activity monitor wearability criteria; see vendor guidance)
- For France only, affiliated with or benefiting from a social security system
Who cannot join
- Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
- Person under guardianship or curatorship
- Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
- Participant has participated in another interventional clinical study within 30 days prior to screening or who are currently enrolled in another study that, in the - Investigator's opinion, could interfere with their full participation in this study or confound the assessment of the subject or study outcomes
- For France only, participant who has received more than €6,000 in compensation over the past 12 months for participating in human research, clinical trials, clinical investigations or performance studies.
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
France7 sites, 7 recruiting
- Recruiting
CHU de Brest, La Cavale Blanche
Brest, Brittany Region, 29609
Dr Jean-Baptiste NOURY, +33230337912, jean-baptiste.noury@chu-brest.fr
- Not yet recruiting
CH Raymond Poincaré
Garches, 92380
Pr LAFORÊT, +33 0147104615, pascal.laforet@aphp.fr
- Not yet recruiting
CHRU de Nancy
Nancy, 54035
Dr MICHAUD, +330383852538, m.michaud@chru-nancy.fr
- Not yet recruiting
CHU Nantes
Nantes, 44093
Pr PEREON, 0240083771, yann.pereon@univ-nantes.fr
- Not yet recruiting
CHU de Nice - Hôpital Pasteur 2
Nice, 06100
PR SACCONI, +33 0492037267, sacconi.s@chu-nice.fr
- Not yet recruiting
Hôpital Hautepierre
Strasbourg, 67098
Dr NADAJ-PAKLEZA, +33 0388128938, aleksandra.nadaj-pakleza@chru-strasbourg.fr
- Recruiting
Hôpital Pierre Paul Riquet
Toulouse, 31059
Dr ACKET, +33 0534558700, acket.b@chu-toulouse.fr
Italy4 sites, 4 recruiting
- Not yet recruiting
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milan
Dr Maggi, +39 02 23943568, lorenzo.maggi@istituto-besta.it
- Not yet recruiting
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia
Dr Gastaldi, matteo.gastaldi@mondino.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa
Dr Maestri, 039 (0)50 996183, m.maestri@ao-pisa.toscana.it
- Not yet recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Pr Iorio, raffaele.iorio@policlinicogemelli.it
Spain4 sites, 4 recruiting
- Not yet recruiting
Hospital Universitari de Bellvitge
Barcelona
Dr Vélez Santamaría, +34636886285, pvelezsantamaria@bellvitgehospital.cat
- Not yet recruiting
Hospital Universitario La Paz
Madrid, 28046
Dr Rodríguez de Rivera Garrido, +34917277444, frriveragarrido@salud.madrid.org
- Not yet recruiting
Hospital Universitario Infanta Sofía
Madrid
Dr Gutiérrez Gutiérrez, +34 676454278, g3.neuro@gmail.com
- Not yet recruiting
Hospital de día de Neurología
Santiago de Compostela, 15706
Dr Canneti Heredia, +34 981951351, Beatrice.Canneti.Heredia@sergas.es
Germany3 sites, 3 recruiting
- Not yet recruiting
Charite Berlin
Berlin
Prof Andreas Meisel, +49 30 450 539 720, andreas.meisel@charite.de
- Not yet recruiting
Universitätsklinikum Bergmannsheil Bochum
Bochum
Pr Kleefeld, +49 (0)234 302-3118, felix.kleefeld@bergmannsheil.de
- Not yet recruiting
LMU Klinikum
München
Dr Havla, joachim.havla@med.uni-muenchen.de
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, DK-8200
Pr Andersen, hennande@rm.dk
- Not yet recruiting
Rigshospitalet
Copenhagen, DK-2100
Dr Rasmus Preisler, +45 3545 9473, nicolai.rasmus.preisler@regionh.dk
About this study
The purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Its main objective is not yet to demonstrate the final conformity of the device (exploratory study under article 82), but to collect preliminary data of safety and clinical performance that will help to refine the final product and inform the subsequent pivotal study.
The primary objective focuses on developing models to detect disease trajectory changes defined by the clinically significant +/- 2 points MG-ADL threshold. Secondary objectives include assessing usability, adherence, and the feasibility of models for worsening/exacerbation prediction. Finally, risks and anticipated Adverse Device Effects (ADEs) associated with the device use will be monitored continuously throughout the investigation. Consistent with its Proof of Concept stage, the study defines no claims of clinical performance, effectiveness or safety.
- Conditions
- Myasthenia Gravis, Generalized
- Being tested
- MyoSense 360
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoSense 360Device
The investigational version of MyoSense 360 consists of two mobile applications running on the patient's smartphone (CentrePoint Connect and InClinical), an ActiGraph LEAP activity monitor (Ametris product), as well as two cloud computing platforms
| Study group | Role | What they receive |
|---|---|---|
| MyoSense 360 | Experimental | Performance of digital tests (only at D0), digital questionnaires and standard test in clinic at D0, D180 and D360 Use of MyoSense 360 at-home in between visits during 12 months of follow-up and answer ePRO Receives: Device: MyoSense 360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to detect changes in disease trajectory in adults with generalized Myasthenia Gravis over a 12-month period, under real-life, unsupervised conditions.
The primary endpoint will be the ability of the model to detect changes categorized as a 3-class variable:
- improved: decreased Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥2 points
- unchanged: increased or decreased MG-ADL total score <2 points
- worsening: increased MG-ADL total score by ≥2 points
Measured: 12 months
Secondary outcomes (11)
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to predict sustained worsening within a one-month forward-looking window
The first secondary endpoint will be the ability of the model to detect changes categorized as a 2-class variable:
- worsening: increased MG-ADL total score by ≥2 points
- other: either decreased MG-ADL total score ≥2 points or increased or decreased in MG-ADL total score <2 points
Measured: 1 month
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Feasibility of using MyoSense 360 developed models to predict sustained worsening, i.e., an increase by at least 2-points in MG-ADL total score that is sustained within the next 4 weeks (no change observed in the opposite direction) will be described through performance metrics:
- Positive predictive value
Measured: 4 weeks
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Feasibility of using MyoSense 360 developed models to predict sustained worsening, i.e., an increase by at least 2-points in MG-ADL total score that is sustained within the next 4 weeks (no change observed in the opposite direction) will be described through performance metrics:
- time-to-event accuracy
Measured: 4 weeks
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Feasibility of using MyoSense 360 developed models to predict sustained worsening, i.e., an increase by at least 2-points in MG-ADL total score that is sustained within the next 4 weeks (no change observed in the opposite direction) will be described through performance metrics:
- Model robustness across patients.
Measured: 4 weeks
To describe the association between MyoSense 360 active functional tests measures obtained at home without supervision and the standard reference Quantitative Myasthenia Gravis (QMG) sub-items performed under clinical supervision at baseline
A correlation coefficient will be used to assess the relationship between the MyoSense 360 active functional tests at Day 1 (D1, at home) and standard tests at Day 0 (D0, in clinic). The endpoint will be considered positive if one test meets the expected correlation, with a minimum correlation threshold of r = 0.50 for the following comparisons:
- "My Eyelids" Test (MET) and ptosis in QMG
- "My Voice" Test (MVT) and onset of dysarthria in QMG
- "My Breathing" Test (MBT) and vital capacity in QMG
- "My Arms" test (MAT) and upper limb weakness in QMG
- "My Legs" Test (MLT) and lower limb weakness in QMG
Measured: Day 0 and Day 1
To describe the association between digital measures from MyoSense 360 (ActiGraph LEAP data collection, active smartphone functional tests and electronic Patient-Reported Outcomes) and clinical and patient-reported outcome measures
Cross-sectional and longitudinal associations between MyoSense 360 digital measures and clinical and patient-reported outcomes measured through questionnaires will be described using mixed-models
Measured: 12 months
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed
Compliance to MyoSense 360 will be described through:
- The number of days with valid* data collection from the wearable device.
*The minimum requirement is 8 hours of daytime wear per day, with at least 60% daily compliance throughout the one-year follow-up period. Additionally, patients should wear the ActiGraph LEAP during at least two nights per week to capture relevant sleep and resting heart rate measures.
Measured: 12 months
To describe the usability of MyoSense 360, including ActiGraph LEAP data collection, active functional tests and ePROs, from the patient's perspective.
Usability of MyoSense 360 will be described using the System Usability Scale (SUS):
- A descriptive analysis of the responses collected in the SUS related to the use of MyoSense 360 at Days 1, 180 and 345
Measured: Days 1, 180 and 345
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed
Compliance to MyoSense 360 will be described through:
- The proportion of scheduled active functional tests completed per patient over time in comparison to the total expected
Measured: 12 months
To describe overall patient satisfaction and perceived benefits of using MyoSense 360 in daily life
Descriptive analysis of the answers collected in the patient's satisfaction and perceived benefits questionnaires related to the use of MyoSense 360
Measured: Days 1, 180 and 345
To monitor the incidence, type, and severity of adverse events and device deficiencies related to the use of MyoSense 360.
All adverse events (AEs), serious adverse events (SAEs) and Device Deficiencies (DD), and new findings on previous SAEs and DDs, suspected to be related to MyoSense 360 or not, will be prospectively collected from the first device use until 30 days after the last study activity, in line with ISO 14155:2020 and EU MDR 2017/745.
Measured: 390 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start6 Oct 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, GeneralizedStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323316
- Sponsor's protocol ID
- ADS-HARMONY360-2025
- Acronym
- HARMONY 360
- Status last verified
- Nov 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
- ClinicalTrials.gov ID
- NCT07323316
- Acronym / sponsor ID
- HARMONY 360 / ADS-HARMONY360-2025
- Conditions
- Myasthenia Gravis, Generalized
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 7 Jan 2026 (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 purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Its main objective is not yet to demonstrate the final conformity of the device (exploratory study under article 82), but to collect preliminary data of safety and clinical performance that will help to refine the final product and inform the subsequent pivotal study.
The primary objective focuses on developing models to detect disease trajectory changes defined by the clinically significant +/- 2 points MG-ADL threshold. Secondary objectives include assessing usability, adherence, and the feasibility of models for worsening/exacerbation prediction. Finally, risks and anticipated Adverse Device Effects (ADEs) associated with the device use will be monitored continuously throughout the investigation. Consistent with its Proof of Concept stage, the study defines no claims of clinical performance, effectiveness or safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoSense 360 | Experimental | Device: MyoSense 360Performance of digital tests (only at D0), digital questionnaires and standard test in clinic at D0, D180 and D360 Use of MyoSense 360 at-home in between visits during 12 months of follow-up and answer ePRO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years at screening
- Patients with gMG diagnosis confirmed by the investigator based at least on one of the following:
- Positive antibody testing for ACHR or MuSK antibodies; or,
- MGFA Class IIa to IVb
- Having read the information sheet and signed the informed consent form
Key exclusion criteria (5 listed)
- Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
- Person under guardianship or curatorship
- Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
- Participant has participated in another interventional clinical study within 30 days prior to screening or who are currently enrolled in another study that, in the - Investigator's opinion, could interfere with their full participation in this study or confound the assessment of the subject or study outcomes
- For France only, participant who has received more than €6,000 in compensation over the past 12 months for participating in human research, clinical trials, clinical investigations or performance studies.
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 |
|---|---|---|
| MyoSense 360The investigational version of MyoSense 360 consists of two mobile applications running on the patient's smartphone (CentrePoint Connect and InClinical), an ActiGraph LEAP activity monitor (Ametris product), as well as two cloud computing platforms | Device | MyoSense 360 |
Primary outcome
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to detect changes in disease trajectory in adults with generalized Myasthenia Gravis over a 12-month period, under real-life, unsupervised conditions.
Time frame: 12 months
The primary endpoint will be the ability of the model to detect changes categorized as a 3-class variable: * improved: decreased Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥2 points * unchanged: increased or decreased MG-ADL total score <2 points * worsening: increased MG-ADL total score by ≥2 points
11 secondary outcomes
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to predict sustained worsening within a one-month forward-looking window
Time frame: 1 month
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Time frame: 4 weeks
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Time frame: 4 weeks
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Time frame: 4 weeks
To describe the association between MyoSense 360 active functional tests measures obtained at home without supervision and the standard reference Quantitative Myasthenia Gravis (QMG) sub-items performed under clinical supervision at baseline
Time frame: Day 0 and Day 1
To describe the association between digital measures from MyoSense 360 (ActiGraph LEAP data collection, active smartphone functional tests and electronic Patient-Reported Outcomes) and clinical and patient-reported outcome measures
Time frame: 12 months
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed
Time frame: 12 months
To describe the usability of MyoSense 360, including ActiGraph LEAP data collection, active functional tests and ePROs, from the patient's perspective.
Time frame: Days 1, 180 and 345
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed
Time frame: 12 months
To describe overall patient satisfaction and perceived benefits of using MyoSense 360 in daily life
Time frame: Days 1, 180 and 345
To monitor the incidence, type, and severity of adverse events and device deficiencies related to the use of MyoSense 360.
Time frame: 390 days
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 5 Nov 2026.
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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.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoSense 360 in people with Myasthenia Gravis, Generalized, run by Ad scientiam at 20 sites in 5 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 12 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Italy, Spain, Germany, Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to detect changes in disease trajectory in adults with generalized Myasthenia Gravis over a 12-month period, under real-life, unsupervised conditions. (time frame: 12 months). 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 5 Nov 2026.