RT info:eu-repo/semantics/article
T1 Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial
A1 Matias Guiu, Jordi A.
A1 González Rosa, Javier
A1 Hernández, Miguel Ángel
A1 Martínez Ginés, María Luisa
A1 Portolés, Antonio
A1 Pérez Macías, Natalia
A1 Benito León, Julián
A1 Padrón González, Iván
A1 Prieto, Julio
A1 Matias Guiu, Jorge
K1 Esclerosis múltiple
K1 FETEM
K1 Estimulación magnética
AB Introduction Fatigue is one of the most disabling symptomsof multiple sclerosis (MS), and effective treatments arelacking. Amantadine is one of the most used treatments,although its efficacy is under debate. Transcranial magneticstimulation (TMS) is a promising intervention that has shownpositive effects in some preliminary investigations. We aim toinvestigate the effect of 6weeks of amantadine and/or TMS infatigue due to MS.Methods and analysis The study is a national, multicentre,phase 3, randomised, double-blind, cross-over, placebocontrolled and sham-controlled clinical trial. Adult patientswith relapsing-remitting MS, Expanded Disability StatusScale score of 1.5–4.5 and Fatigue Severity Score>4 areeligible for the trial. Participants will be randomised to one ofthe sequences of the study. Each sequence consists of fourperiods of 6 weeks of treatment and three washout periodsof 12–18 weeks. All patients will receive all the combinationsof therapies. The primary outcome is the Modified FatigueImpact Scale. The secondary outcomes are the Symbol DigitModalities Test (cognition), Beck Depression Inventory-II(depressive symptoms) and Short-Survey 12 (quality of life).Safety and cost-effectiveness will also be evaluated. Anexploratory substudy including MRI and blood biomarkers willbe conducted.Ethics and dissemination The study is approved by theEthics Committee of the Hospital Clinico San Carlos andthe Spanish Agency of Medications and Medical Devices.All study findings will be published in scientific peerreviewed journals and presented at relevant scientific conferences.Trial registration number EudraCT 2021-004868-95; NCT05809414.
YR 2023
FD 2023
LK http://riull.ull.es/xmlui/handle/915/35582
UL http://riull.ull.es/xmlui/handle/915/35582
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 12-jun-2024