Relapsing-remitting multiple sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: Patients in the case group are treated with Levetiracetam for 16 weeks from a reputable Abidi Pharmaceutical Factory. The initial dose is 250 mg (half a tablet) twi
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients with relapsing-remitting multiplesclerosis age between 18 and 60 years Have a minimum education to perform cognitive tests RRMS (2017 Revisions of the “McDonald” Criteria ) At least 2 years have passed since the definitive diagnosis of the disease Receiving first-line injectable and oral disease modifying drugs (interferon beta, glatiramer acetate, triflunomide and dimethyl fumarate) Type and dose of DMD have not changed in the last six months Have not received corticosteroids in last 30 days Have not relapse in the last 60 days Expanded Disability Status Scale (EDSS) scores of 5.5 or less Voluntarily participated in the present study
Exclusion criteria
Exclusion criteria: History of drug or alcohol abuse in the last six months Pregnancy and lactation Having any acute or major mental disorder that is not under control (type of medication and amount of use in the last three months is constant) Having any seizure disorder History of any suicide attempt Chronic kidney disease (Estimated glomerular filtration rate less than 60 ml / min) Diabetes, hypothyroidism and anemia that is not under control Concomitant use of drugs that may affect cognitive function, such as antipsychotics, modafinil, methylphenidate, amphetamine and amphetamine-like compounds, tricyclic antidepressants and anticonvulsants other than gabapentin and pregabalin, benzodiazepines other than as sleeping pills Avar (if the dose and method of medication do not change in the last three months and during the study will not be prohibited).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Assessment of Cognitive Function In Multiple Sclerosis (MACFIMS). Timepoint: Beginning of study and end of week 16. Method of measurement: MACFIMS questionnaire.;California Verbal Learning Test (CVLT). Timepoint: Beginning of study and end of week 16. Method of measurement: California Verbal Learning Test (CVLT).;Brief Visuospatial Memory Test Revised (BVMT). Timepoint: Beginning of study and end of week 16. Method of measurement: Brief Visuospatial Memory Test Revised (BVMT).;Paced Auditory Seaial Addition Test(PASAT). Timepoint: Beginning of study and end of week 16. Method of measurement: Paced Auditory Seaial Addition Test(PASAT).;Symbol Digit Modalitis Testing(SDMT). Timepoint: Beginning of study and end of week 16. Method of measurement: Symbol Digit Modalitis Testing(SDMT).;Delis-Kaplan Executive Function System(D-KEFS). Timepoint: Beginning of study and end of week 16. Method of measurement: Delis-Kaplan Executive Function System(D-KEFS).;Controlled Oral Word Association Test(COWAT). Timepoint: Beginning of study and end of week 16. Method of measurement: Controlled Oral Word Association Test(VCOWAT).;Judgment of Line Orientation(JLO). Timepoint: Beginning of study and end of week 16. Method of measurement: Judgment of Line Orientation(JLO). | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychiatry Complications of levetiracetam. Timepoint: The end of the fourth and sixteenth week. Method of measurement: Neuropsychiatry Inventory (NPI).;Possible side effects of Levetiracetam. Timepoint: Every two weeks until the end of 16 weeks. Method of measurement: Case report form (CRF).;White blood cells from blood cells and part of the immune system. Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test.;Hemoglobin. Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test.;Platelet. Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test.;Alanine amino trans ferase ( ALT). Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test.;Aspartate amino transferase. Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test.;Cratinine. Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test.;Blood urea nitrogen (BUN). Timepoint: Beginning of study and end of week 16. Method of measurement: Blood test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHooshyar Honarmand
Tehran University of Medical Sciences
Outcome results
None listed