The aim of the present study is to compare the therapeutic effects of amantidine and Modafinil in fatigue related multiple sclerosis in Neshat clinic (Hamedan).
Design
This study will be a double blind clinical trial . This study will be performed in parallel on two groups of patients (Amantidine as control group and Modafinil group).
Settings and conduct
This study is a double blind clinical trial that will be performed at Nashat MS clinic of Hamedan. The attending physician, evaluating neurology resident and patients will be unaware of the types of medication which patients are taking. Patients will be divided into intervention group or modafinil group (200mg/day) and control group or amantadine group(100 mg/day) based on which they will receive the drugs for three months.
Participants/Inclusion and exclusion criteria
Patients of Multiple Sclerosis (Age:16-55) which suffer from fatigue and do not have history of systemic disease are included in the study and patients who smoke or have history of psychosis were excluded from the study.
Intervention groups
Group1 control group with Amantadine :which will be received 100 mg daily in 3 month
Group 2 intervention group with Modafinil: which will received 200 mg daily in 3 month
Main outcome variables
Fatigue rate based on FSS questionnaire
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20210511051267N1
Registration date:2021-06-22, 1400/04/01
Registration timing:prospective
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Masoud Ghiasian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0703
Email address
m.ghiasian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Therapeutic Effect of Amantidine and Modafinil in Fatigue Related Multiple Sclerosis Patients in Hamedan M.S Clinic (Neshat)
Public title
Comparison of Therapeutic Effect of Amantidine and Modafinil in Fatigue Related Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age(16-55)
Fatigue related to MS
Satisfaction for participation in the study
Exclusion criteria:
Narcolepsy
Sleep apnea
Major systemic disorder
late use of Drowsiness and fatigue drugs
Smoker
Clinical history of thyroid, renal, cardiovascular disorders and diabetes and hepatitis
Depression
History of psychotic diseases
Age
From 16 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, we will use the method of balanced block randomization (block size: Four). For this purpose, we prepare four sheets of paper. On the two sheets, we write the I meaning "Intervention" and on the other two sheets we write the P meaning "Placebo". Mix the sheets together, and place them on the desk drawer. When referring to any of the eligible patients, one of the sheets was randomly taken out and based on this sheet, I or P was assigned to one of the two groups of intervention (Modafinil recipient) or comparison (Amantadine recipient). Extracted tabs will not be returned to the drawer until all four tabs have been extracted. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desire sample size (150 patients) is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Executors of the research project (Attend and evaluating neurology resident) and statistical analysis colleague and also the patients will be unaware of the types of the drugs for each treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Daneshgah Street, Hamedan University of Medical Sciences, Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.UMSHA.REC.1400.119
2
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Daneshgah Street, Hamedan University of Medical Sciences, Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.UMSHA.REC.1400.119
Health conditions studied
1
Description of health condition studied
Fatigue related to multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple scle
Primary outcomes
1
Description
Fatigue rate based on FSS questionnaire(fatigue severity scale)
Timepoint
At the beginning of the study and after three months of receiving the drugs
Method of measurement
In this study fatigue will be evaluated by standard fatigue severity scale questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:treatment groups
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neshat Rehabilitation clinic
Full name of responsible person
Masoud Ghiasian
Street address
Neshat clinic,Javan Blvd,Saidiyeh Street,Near Tizhiooshan high school, Hamedan,Iran