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NCT05575843: SMARTCARE

Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®

Completed NA Last updated 23 July 2024
What this trial tests

NA trial testing Neurostatus-SMARTCARE in Multiple Sclerosis (MS) in 101 participants. Completed in 1 March 2024.

Timeline
9 December 2022
Primary endpoint
17 November 2023
1 March 2024

Quick facts

Lead sponsorUniversity Hospital, Basel, Switzerland
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposeother
Enrollment101
Start date9 December 2022
Primary completion17 November 2023
Estimated completion1 March 2024
Sites2 locations across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Multiple Sclerosis (MS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Expanded Disability Status Scale (EDSS) is the gold-standard in assessing disability in Multiple Sclerosis (MS). Its current digital form, the Neurostatus-eEDSS®, often serves as primary endpoint in MS clinical trials. The pandemic revealed the need for telemedical alternatives to the in-clinic assessment. Therefore, Neurostatus-SMARTCARE was developed: A trained and certified non-neurologist Health Care Professional (HCP) examines the patient while the examination is being video-recorded. The stored video allows a neurologist to re-assess the examination at a later point of time. The future application could be in-home visits through HCPs, in decentralized clinical trials as well as in routine care. In this study, the concordance rate of Neurostatus examinations between neurologists and HCPs is investigated. With a concordance rate significantly higher than 80%, Neurostatus-SMARTCARE by HCPs can be considered equal to the standard Neurostatus-EDSS by neurologists.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.
    Mallucci G, Zimmer A, Sfikas N, Cerdá-Fuertes N, et al · · 2025 · cited 2× · PMID 39704409 · DOI 10.1177/13524585241305966

Verify or expand the search:

Other recruiting trials for Multiple Sclerosis (MS)

Currently open trials in the same condition.

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05575843.

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