Amantadine hydrochloride for Multiple sclerosis

Inclusion criteria

• {"criterion_text":"- 1. Disability scale score (EDSS) at the time of recruitment (1, 5 to 4.5 points). 2. Fatigue Severity Scale (FSS) score greater than 4 points. 3. Beck Depression Inventory (BDI) score less than 30 points. 4. Not having presented an outbreak of the disease in at least three months prior to recruitment. recruitment. 5. Having undergone a four-week washout for any fatigue-related drugs related to fatigue: amantadine, modafinil, methylphenidate, acetyl-L-carnitine, cannabinol (delta-9-tetrahydrocannabinol, delta-9-tetrahydrocannabinol), cannabinol (delta-9-tetrahydrocannabinol and cannabidiol from Cannabis sativa L) and fampridine. fampridine. 6. Patient able to sign the Informed Consent form."}

Exclusion criteria

• {"criterion_text":"- 1. Patient diagnosed with a disease other than MS that may cause fatigue such as (but not limited to): a.\tPatient diagnosed with sleep apnoea treated with CPAP or not and who can justify fatigue apart from the disease. b.\tPatient with another associated autoimmune or rheumatological disease (lupus, rheumatoid arthritis...) that may justify the fatigue. In case of endocrine immune diseases, the patient is allowed to participate in the study if the analytical parameters are in range in the last 6 months and do not justify the fatigue. c.\tPatients with immune endocrine diseases. Inclusion is only allowed if the analytical parameters are in range in the last 6 months. d.\tPatients with diagnostic criteria for chronic fatigue syndrome. e.\tPatients with poorly controlled arterial hypertension or with decompensated, terminal or NYHA 3-4 heart failure. 2.\tSecondary epilepsy. 3.\tPresent contraindications related to the treatments to be used (TMS or amantadine) such as: (a) Magnetically-sensitive metal on the head or within 12 inches (30.5 cm) of the TMS coil that cannot be removed. Objects that may contain such metal include: aneurysm clips or coils; carotid or cerebral stents; implanted stimulators; electrodes; ferromagnetic implants in the ears or eyes; bullets or shrapnel fragments; metal pellets, bullets or fragments; magnetically activated dental implants. b) History of epilepsy. c) Drugs that may lower the seizure threshold (antidepressants such as tricyclic antidepressants, antipsychotics, etc.). SSRIs are permitted at stable doses for the last 6 months. d) Hypersensitivity to amantadine. e) Severe heart disease, severe renal failure, angle-closure glaucoma. 4.\tBreast-feeding, pregnancy, or planning pregnancy in the next year. In case of fertile women, they must commit to the use of contraceptives throughout the study. In case of doubt at the time of inclusion, a pregnancy test will be performed. 5.\tPatients with a terminal medical illness with a life expectancy of less than one year. 6.\tPatient treated for malignant disease within the last three years. 7.\tPlanning surgery during the trial period. 8.\tAny condition considered by the investigator team that may preclude participation/follow-up in the trial. 9.\tAlcohol or substance abuse within the past year. 10.\tMajor psychiatric disorders (schizophrenia, schizoaffective disorders, bipolar, or obsessive-compulsive disorders, personality disorders). 11.\tInability to communicate, poor command of the language or cognitive impairment that, in the opinion of the researcher, renders him/her incapable of carrying out the study. 12.\tParticipation in another clinical trial with medication in the 4 months prior to inclusion. 13.\tChronic use of drugs that may influence the results (unless they can be withdrawn prior to the start of the study): a.\tAntiepileptic drugs. Allowed in stable doses 3 months prior to inclusion. If it is necessary during the study because the patient has an epileptic seizure, it can be added. b.\tDiazepam and derivatives except in stable doses 3 months prior to inclusion. Modifications are permitted during the study. c.\tBaclofen, must be withdrawn with a period equal to or greater than 5 half-lives. d.\tSSRIs (Selective Serotonin Reuptake Inhibitors) except at stable doses 3 months prior to inclusion. If necessary during the study, may be added. e.\tDrugs that may lower the seizure threshold (antidepressants such as tricyclic antidepressants, antipsychotics, etc.). They are allowed in stable doses 3 months prior to inclusion. If necessary during the study, they can be added."}

Primary endpoints

• {"endpoint_text":"- The change in the values of the MFIS questionnaire is considered as the main study variable for the evaluation of effectiveness.","definition_or_measurement_approach":"Change in MFIS (Modified Fatigue Impact Scale) questionnaire scores; main assessment at 6 weeks as per main objective."}

Secondary endpoints

• {"endpoint_text":"- Patient-perceived quality of life. The change in the mean score of the patient-perceived quality of life scale (SF-12) between the time of inclusion in the study and at the beginning and end of each phase will be assessed.\n- Beck Depression Inventory-II to assess depressive symptomatology. The assessment will be made at inclusion, and at the beginning and end of each phase.\n- Total costs per patient. Total costs of hospitalisation and treatment as well as other health care will be measured. -","definition_or_measurement_approach":"SF-12: change in mean score between inclusion and at the beginning and end of each phase; BDI-II: assessed at inclusion and at the beginning and end of each phase; Total costs: measurement of total hospitalization, treatment and other healthcare costs per patient."}

Spain

Earliest CTIS Part Ii Submission Date

09-09-2024

Latest Decision Or Authorization Date

11-09-2024

Processing Time Days

2

Number Of Sites

4

Number Of Participants

144

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain