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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090429001859N11
Enrollment
48
Registered
2023-09-10
Start date
2023-09-23
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Multiple Sclerosis. Condition 2: Dysphagia. Multiple sclerosis Dysphagia

Interventions

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

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Hamidi

Tehran University of Medical Sciences

hamidi.majid.96@gmail.com+98 21 6634 8500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026