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Investigation of Subclinical Markers of Multiple Sclerosis

Study acronym: SUBCLIN-MS
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated October 2, 2023 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Feb 2023 to Dec 2024
    • Study completion date: Feb 2024 to Dec 31, 2028
    • Study title expanded, about 2 words
    v4
  2. Enrollment target: 20 to 50v3 Show 11 more changesShow less
    • Primary completion date: Nov 2021 to Feb 2023
    • Primary endpoints: 25 to 28
    • Study completion date: Nov 2022 to Feb 2024
    • Interventions: Neurophysiological techniques (TMS, EMNG), Immunological methods, Neuropsychological tests (Diagnostic Test) to 1. Clinical testing; 2. Neurophysiological examination (TMS, EMNG); 3. Psychomotor examination; 4. Neuropsychological evaluation; 5. Flow…
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoint revised
    • Site contact updated
    • Publications: 9 to 13
    • Study arms: 0 to 3
    • Study description shortened, about 2 words
    • Study title shortened, about 4 words
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 2021 to Nov 2021
    • Study completion date: Oct 2022 to Nov 2022
    • Start date changed from estimate of Oct 2020 to Nov 23, 2020
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Transcranial magnetic stimulation (TMS) studies reported consistent and substantial impairments in the central nervous system (CNS) in multiple sclerosis (MS). Studies of peripheral nervous system (PNS) function comprising electromyoneurography (EMNG) reported impairments of the PNS in MS that were less pronounced and inconsistent. Neurophysiological studies are generally small and cross-sectional and with the poor grouping of MS patients according to MS type. The objective of the study is to investigate clinical, neurophysiological, and immunological markers in relapsing-remitting MS patients, and in patients with relapsing-remitting MS treated with immunomodulation. The results of the study may contribute to a better understanding of the pathophysiology of multiple sclerosis and can provide guidance in the diagnosis and treatment of patients with relapsing-remitting MS.
Trial Details
NCT Number NCT04604041
Lead Sponsor University of Split, School of Medicine
Collaborators: University Hospital of Split
Conditions
(from sponsor)		 Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
Related terms Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov