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NCT05575843: SMARTCARE
Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®
NA trial testing Neurostatus-SMARTCARE in Multiple Sclerosis (MS) in 101 participants. Completed in 1 March 2024.
17 November 2023
Quick facts
| Lead sponsor | University Hospital, Basel, Switzerland |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 101 |
| Start date | 9 December 2022 |
| Primary completion | 17 November 2023 |
| Estimated completion | 1 March 2024 |
| Sites | 2 locations across Switzerland |
Drugs / interventions tested
- Neurostatus-SMARTCARE
- Standard Neurostatus-EDSS
Conditions studied
- Multiple Sclerosis (MS) — all drugs for Multiple Sclerosis (MS) →
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):
-
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:
- PubMed search for NCT05575843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Basel, Switzerland trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05575843 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Basel, Switzerland
- Last refreshed: 23 July 2024
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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