Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis

PHASE3RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

November 28, 2022

Primary Completion Date

July 15, 2024

Study Completion Date

February 28, 2025

Conditions
Multiple SclerosisFatigue
Interventions
DEVICE

Transcranial Magnetic Stimulation

"TMS is a technique for electrical stimulation of brain tissue by generating a magnetic field, which modulates neural activity at the stimulation site and in interconnected neural networks.~The treatment will be applied to the left dorsolateral prefrontal region. Each patient will receive 3 sessions per week of approximately 10 minutes for 6 weeks.~In the case of TMS sham, a placebo coil will be used, which is indistinguishable from the therapeutic one. In addition, the sessions will be carried out with the same frequency, so the patient will be unaware of the treatment they are receiving."

DRUG

Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule

"It will be used at a dose of 100 mg, 1 capsule a day for 1 week, followed by 2 daily doses of 100 mg until completing 6 weeks in total. After completing the treatment phase, the dose will be de-escalated (1 capsule a day for 5 days and discontinued).~In the case of placebo amantadine capsules, they will have the same organoleptic characteristics as amantadine. The start, maintenance and de-escalation pattern will be identical."

Trial Locations (4)

11009

RECRUITING

Hospital Puerta del Mar, Cadiz

28007

RECRUITING

Hospital General Gregorio Marañon, Madrid

28040

RECRUITING

Hospital Clínico San Carlos, Madrid

38010

RECRUITING

Hospitalario Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife

All Listed Sponsors
lead

Hospital San Carlos, Madrid

OTHER