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IRCT20090429001859N11 IRCT 2023-09-10 Tehran University of Medical Sciences The Effects of Pyridostigmine on Dysphagia in Patients With Multiple Sclerosis Studying the Effects of Pyridostigmine on Dysphagia in Patients With Multiple Sclerosis: a Randomized Triple-Blind Placebo-Controlled Clinical Trial 2023-09-23 anticipated 48 Complete https://irct.ir/trial/72487 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by classifying participants into pyridostigmine and placebo groups, using non-stratified block randomization with blocks of 4, containing 2 spots for pyridostigmine and 2 spots for placebo each. A computer generated list will be prepared, which will have letters "A" and "B" assigned to each group of pyridostigmine or placebo. Then an ID will be assigned to each spot in the blocks in that list, using a combination of 4 English characters (digits or letters, e.g. T1D8). The same IDs will be put on drug containers. Study conductors will use an ordered list of these IDs and will deliver the participants their IDs and and the corresponding drug containers, based on the order of IDs list and the order of participation, Blinding description: In order to make this study triple blinded, all the steps of block randomization will be done by a person who is not involved in this study, which consists of preparing the computer generated randomized list, computer generated IDs, assigning the IDs to blocks and preparing the order of IDs. These IDs will be put on the containers and then the container will be filled with either pyridostigmine or placebo, in regards with their position in the blocks (A or B) by the same person. Then the containers will be passed to study conductors along with the order of the IDs. Thus the participants, researchers, neurologists, and data analysts will be fully blinded. The list that decrypts whether each ID has received placebo or pyridostigmine will be received and opened at the end of the study and only after complete analysis of results. N/A Condition 1: Multiple Sclerosis. Condition 2: Dysphagia. Intervention 1: Intervention group: pyridostigmine tablet. The duration of intervention is 3 weeks. For the first 4 days of the study, this group will have half a 60 mg tablet of pyridostigmine, three times a day, 30 minutes before breakfast, lunch and dinner. During the following 3 days (until the end of first week), the dose before lunch is increased to a complete 60 mg tablet. In the next 3 days, the patient will have the dose before breakfast increased to a complete tablet, and then after that will continue on a 60 mg dose of pyridostigmoine, PO, three times a day, until the end of third week. Intervention 2: Control group: placebo tablet. The duration of intervention is 3 weeks. For the first 4 days of the study, this group will have half a 60 mg tablet of placebo, three times a day, 30 minutes before breakfast, lunch and dinner. During the following 3 days (until the end of first week), the dose before lunch is increased to a complete 60 mg tablet. In the next 3 days, the patient will have the dose before breakfast increased to a complete tablet, and then after that will continue on a 60 mg dose of placebo, PO, three times a day, until the end of third week. The dosage of placebo group is completely similar to the one of the pyridostigmine group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Majid Hamidi
MS Research Institute, Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave., 12th District
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 hamidi.majid.96@gmail.com Tehran University of Medical Sciences scientific Dr. MohammadAli Sahraian
Sina Hospital, Hasan abad Sq., Imam Khomeini Ave., 12th District
Tehran Iran (Islamic Republic of) 1136746911 +9866348500 sahraian1350@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) A diagnosis of multiple sclerosis is made by a neurologist specialized in multiple sclerosis, based on the 2017 McDonald criteria, and the patient is receiving treatment for multiple sclerosis. After explaining the goals and methods of the study and all the sections of the informed consent form, the patient is willing towards participation and cooperation. The patient has a DYMUS score of at least 3, based on the persian version of the questionnaire. 18 years 55 years Both Any comorbidity due to previous neurological disorders, e.g. previous cerebrovascular accidents. Other neurological disorders A history of relapse (if MS type is relapsing-remitting) in the previous 3 months. An Expanded Disability Status Scale (EDSS) score above 7.5. Currently being under treatment with pyridostigmine for any reasons. A history of hypersensitivity to anticholinesterase inhibitors or any of the compounds found in our placebo. The patient has mechanical obstruction in intestinal or urinary tract. The patient is currently pregnant or breastfeeding. Dysphagia caused by other disorders than MS. Having a decision to start any other treatment for dysphagia in time of the study, or having started in the last 3 months. G35 R13.1 Multiple sclerosis Dysphagia Treatment - Drugs Placebo Intervention group: pyridostigmine tablet. The duration of intervention is 3 weeks. For the first 4 days of the study, this group will have half a 60 mg tablet of pyridostigmine, three times a day, 30 minutes before breakfast, lunch and dinner. During the following 3 days (until the end of first week), the dose before lunch is increased to a complete 60 mg tablet. In the next 3 days, the patient will have the dose before breakfast increased to a complete tablet, and then after that will continue on a 60 mg dose of pyridostigmoine, PO, three times a day, until the end of third week. Control group: placebo tablet. The duration of intervention is 3 weeks. For the first 4 days of the study, this group will have half a 60 mg tablet of placebo, three times a day, 30 minutes before breakfast, lunch and dinner. During the following 3 days (until the end of first week), the dose before lunch is increased to a complete 60 mg tablet. In the next 3 days, the patient will have the dose before breakfast increased to a complete tablet, and then after that will continue on a 60 mg dose of placebo, PO, three times a day, until the end of third week. The dosage of placebo group is completely similar to the one of the pyridostigmine group. Patient's score based on the Persian version of DYMUS questionnaire. Timepoint: In the beginning of the study, and after 1 and 3 weeks of intervention. Method of measurement: Persian version of DYMUS questionnaire. Patient's score based on the Persian version of EAT-10 questionnaire. Timepoint: In the beginning of the study, and after 1 and 3 weeks of intervention. Method of measurement: Persian version of EAT-10 questionnaire. Patient's score based on the Persian version of SWAL-QOL questionnaire. Timepoint: In the beginning of the study, and after 3 weeks of intervention. Method of measurement: Persian version of SWAL-QOL questionnaire. Tehran University of Medical Sciences Approved 2023-09-03 Research Ethics Committees of Sina Hospital Sina Hospital, Hasan Abad Sq.,Imam Khomeini Ave., 12th district Tehran Tehran Iran (Islamic Republic of)