RT journal 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
A1 González Rosa, Javier Jesús
A1 Hernández, Miguel Ángel
A1 Martínez-Ginés, Maria Luisa
A1 Portolés, Antonio
A1 Pérez-Macías, Natalia
A1 Benito-León, Julián
A1 Padrón, Iván
A1 Prieto, Julio
A1 Matias-Guiu, Jorge
A2 Psicología
AB Introduction Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.Methods and analysis The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.Ethics and dissemination The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.
PB BMJ
SN 2044-6055
YR 2024
FD 2024
LK http://hdl.handle.net/10498/32753
UL http://hdl.handle.net/10498/32753
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 11-nov-2026