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IRCT20190804044429N8 IRCT 2022-09-04 Mazandaran University of Medical Sciences Lacosamide efficasy and safety on pain in patients with multiple sclerosis: A randomized double_blind clinical trial Lacosamide efficasy and safety on pain in patients with multiple sclerosis: A randomized double_blind clinical trial 2022-09-23 anticipated 56 Complete https://irct.ir/trial/65347 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block method will be used to allocate the samples to two groups. Blocks will be considered as 4 blocks and in each block of 4 people, two people in the intervention group and two people in the control group will be selected. The selection of the order type in each group for each person will be done through second version of random allocation software, Blinding description: This study is double_ blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo). 3 Pain caused by MS. Intervention 1: Intervention group: Half of the patients in the lacosamide group received lacosamide tablets 100 mg twice a day in the first week, and from the second week, the dose was prescribed as 150 mg every 12 hours, and in the third week, 200 mg twice a day if tolerated. In weeks 0, 4, 8 and 12, they are visited by a neurologist. Intervention 2: Control group: Half of the patients in the control group receive a placebo in the form of tablets with the same color, size and packaging as the intervention group and without the active pharmaceutical ingredient every 12 hours. Yes - There is a plan to make this available What will be shared: Data related to the initial outcoms of the study will be shared When: The data will be available one year after publication To whom: Academic reseachers, medical team and scientific institutes Conditions: Requests for sharing data should be sent to the person responsible for general inquiries Where to obtain: Requests for sharing data should be sent to the person responsible for general inquiries. Ghazaeianm@gmail.com How to obtain: Person in charge of scientific study will reply to the request within 10 days. Comments:
public Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 4815733971 +98 33343011 Ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 4815733971 +98 11 3334 3011 Ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adults over the age of 18 and suffering from MS with moderate to high MS pain complaint 18 years no limit Both Severe depression or suicidal thoughts Thyroid disorders Severe anemia (Hb<9g/dl) Breast feeding or pregnancy History of cerebral ischemia or cardiovascular disease Having kidney failure (creatinine clearance less than 30 ml/min) Existence of an MS attack during the past month Concomitant use of drugs effective in pain control during the last month History of abuse of drugs, psychotropic substances and alcohol History of liver failure History of cardiac arrhythmia or simultaneous use of drugs affecting heart rhythm Failure to receive corticosteroid pulse within a month before the starting of study Absence of a history of structural disorder affecting the occurrence of pain such as discopathy and other disease affecting the occurrence of neuropathic pain( diabetes, trigeminal neuralgia,...) G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: Half of the patients in the lacosamide group received lacosamide tablets 100 mg twice a day in the first week, and from the second week, the dose was prescribed as 150 mg every 12 hours, and in the third week, 200 mg twice a day if tolerated. In weeks 0, 4, 8 and 12, they are visited by a neurologist. Control group: Half of the patients in the control group receive a placebo in the form of tablets with the same color, size and packaging as the intervention group and without the active pharmaceutical ingredient every 12 hours. Intensity of pain caused by MS. Timepoint: Weeks 0-4-8-12. Method of measurement: Brief pain index (BPI). Intensity of pain caused by MS. Timepoint: Weeks 0-4-8-12. Method of measurement: NPSI (Neuropathic Pain Symptom Inventory ). The overall improvement rate of MS patients after taking lacosamide. Timepoint: Weeks 0-4-8-12. Method of measurement: Patient Global Impression of Change (PGIC). The safety of lacosamide in improving pain caused by MS. Timepoint: Weekly. Method of measurement: Patient tolerability. Determining the improvement in function and quality of life of patients with MS following the use of lacosamide. Timepoint: Weeks 0-8-12. Method of measurement: Item Short Form Survey (SF-36). Mazandaran University of Medical Sciences Approved 2022-08-02 Mazandaran university of medical Sciences Ibn Sina hospital, Pasdaran Blvd, Sari town Sari Mazandaran Iran (Islamic Republic of)