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HARMONY 360NCT07323316

Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 2027 to Oct 2028 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Apr 2026 to Oct 6, 2026
    • Eligibility criteria expanded, about 17 words
    • Trial sites expanded: 0 → 20 locations
    • Secondary endpoints: details revised at 10 of 11 entries
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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.
Timeframe: 12 months

Secondary (8)

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
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.
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
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
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
Show 3 moreShow less
To describe the usability of MyoSense 360, including ActiGraph LEAP data collection, active functional tests and ePROs, from the patient's perspective.
To describe overall patient satisfaction and perceived benefits of using MyoSense 360 in daily life
To monitor the incidence, type, and severity of adverse events and device deficiencies related to the use of MyoSense 360.

Arms and interventions

MyoSense 360Experimental

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

Devices: MyoSense 360

Sites

20 sites in 5 countries

France 7, Italy 4, Spain 4, Germany 3, Denmark 2