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IRCT20210707051810N2 IRCT 2021-10-05 Tehran University of Medical Sciences Evaluation of the effect of Levetiracetam on cognitive impairment in patients with MS Evaluation of the effect of Levetiracetam on cognitive impairment in patients with relapsing- remitting multiple sclerosis (RRMS) based on minimal assessment of cognitive function in multiple sclerosis (MACFIMS) 2021-09-23 anticipated 88 Complete https://irct.ir/trial/57352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with relapsing-remitting MS will be divided into two groups by quadruple block randomization. Random sequencing is performed by an epidemiologist using the online program at https://www.sealedenvelope.com/ Hiding is also guaranteed using the block randomization method, Blinding description: The study is a double-blind study and for this purpose, the participants, the main researcher, the health care personnel who are responsible for caring for the patient, do not know which participant received the main drug and which placebo. The end of the evaluation of the results between the two groups will be statistically analyzed.The main researcher is aware of the drug and the placebo of the cans, but remains blind as to which patient receives which drug code. 3 Relapsing-remitting multiple sclerosis. 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) twice a day. 500 mg is added to the daily dose every week, and finally the dose of the drug reaches 1000 mg twice a day. Intervention 2: Control group: Patients in the control group are treated for 16 weeks with a placebo of Levetiracetam prepared by a Abidi Pharmaceutical Factory (Matching placebo). The initial dose of placebo is 250 mg (half a tablet) twice a day. 500 mg is added to the daily dose every week, and finally the dose of the drug reaches 1000 mg twice a day. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the items mentioned in the informed consent, patients' information will not be disseminated.
public Hooshyar Honarmand
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
Tehran Iran (Islamic Republic of) 1136746911 +98 21 8832 2025 Hooshyar1978@gmail.com Tehran University of Medical Sciences scientific Hooshyar Honarmand
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
Tehran Iran (Islamic Republic of) 1136746911 +98 21 8832 2025 Hooshyar1978@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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). G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs 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) twice a day. 500 mg is added to the daily dose every week, and finally the dose of the drug reaches 1000 mg twice a day. Control group: Patients in the control group are treated for 16 weeks with a placebo of Levetiracetam prepared by a Abidi Pharmaceutical Factory (Matching placebo). The initial dose of placebo is 250 mg (half a tablet) twice a day. 500 mg is added to the daily dose every week, and finally the dose of the drug reaches 1000 mg twice a day. 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). 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. Tehran University of Medical Sciences Approved 2021-08-02 Research Ethics Committee of Tehran University of Medical Sciences Tehran, Enghelab Square, 16 Azar St., University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)