Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis (FETEM)
Multiple Sclerosis, Fatigue
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Amantadine, Multiple Sclerosis, Fatigue, Transcranial Magnetic Stimulation (TMS), Modified Fatigue Impact Scale (MFIS)
Eligibility Criteria
Inclusion Criteria: Expanded Disability Status Scale mark 1.5 - 4.5 Fatigue Severity Scale > 4 Beck Depression Inventory < 30 No relapse for, at least, three month prior to screening Drug washout period = 4 weeks for any fatigue aimed drug Patient capable to sign the informed consent Exclusion Criteria: Fatigue causing disease other than multiple sclerosis: sleep apnea other autoimmune disease that could be explain the fatigue. endocrine autoimmune disease if the blood test is not in range in the last 6 month. patient with diagnosis of chronic fatigue Patient with high blood pressure out of range or decompensated heart failure or New York Heart Association (NYHA) 3-4. Secondary Epilepsy or neuropathic chronic pain which requires continuous treatment. Contraindication for trial treatment: Some kind of magnetic metal. Epilepsy antecedents. Any drugs that could decrease the seizure threshold Amantadine sensitivity Cardiopathy disease, severe kidney failure, Angle-closure glaucoma Breastfeeding, pregnancy, or pregnancy planning phase in the next year. Of childbearing potential and willing to use an acceptable method of contraception during the study period. Patient with a terminal disease with no more than one year life expectancy. Patient has been treated for a maligned disease in the past three years. A scheduled surgery in the course of the trials. Any condition that a member of research team consider could affect to participation/follow up patient. Alcoholic o toxics condition in the last year. Major mental disorders Poor communication skills or poor cognitive condition. Other trial participation in the previous 4 month. Use a chronic drug that could interfere in the clinical outcome.
Sites / Locations
- Hospital Puerta del MarRecruiting
- Hospital General Gregorio MarañonRecruiting
- Hospital Clínico San CarlosRecruiting
- Hospitalario Universitario Nuestra Señora de la CandelariaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Sham Comparator
Amantadine
Placebo
TMS
TMS sham