Determining the effect of memantine on fatigue in patients with MS
Design
Patients are assigned to two treatment groups A and B using the method of random blocks ( Balance block randomization ).
The balanced randomization allocation method for the participants in the randomized controlled clinical trial study is the effect of receiving memantine(group A) and placebo (group B) in reducing fatigue.
Settings and conduct
patients with a definite diagnosis of MS ( based on McDonald's diagnostic criteria ) referring to the neurology clinic of Bo Ali Hospital will be randomly included in the study.The intervention group will receive 5mg daily(1 table ) for one week and then 10mg daily(2 tablets) until the end of 3 months of the study.
The control group will receive one placebo pill for one week and then 2 placebo pills until the end of 3 month study.
Participants/Inclusion and exclusion criteria
1.Age 20-50 years
2.EDSS between 0-5
3.Relapsing -Remitting MS
4.Level 3 or 4 fatigue based on the questionnaire
Patients who do not meet the ebove conditions are excluded from the study
Intervention groups
60 patients will be included in the study.The intervention group will receive 5 mg daily (1tablet)for one week and then 10 mg daily (2 tablet) until the end of 3 months of the study.
The control group will receive one placebo pill for one week and then 2 placebo pills until the end 3 months of the study.
Main outcome variables
Physical aspect of MFIS Base/6m/12m ;
Cognitive aspect of MFIS Base/6m/12m ;
Psychosocial aspect of MFIS Base/6m/12m ;
MFIS total score Base/6m/12m
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240118060725N1
Registration date:2024-02-14, 1402/11/25
Registration timing:prospective
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
Registrant information
Name
Fateme Jafarichamandani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4224 8954
Email address
fatemejafari78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of memantine and vitamin B1 in fatigue of patients with multiple sclerosis
Public title
The effect of memantine on fatigue in patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years
EDSS between 0-5
Relapsing-Remitting MS
Grade 3 or 4 fatigue according to the questionnaire
Exclusion criteria:
Use of Modafinil, Ritalin or Amantadine
History of seizures or kidney disease
Taking selective serotonin reuptake inhibitor (SSRI)
Recent attack within the last 3 months
Use of Dalfira
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two treatment groups A and B using the method of random blocks(Balance block randomization), the size of each block is 10 and the total number of blocks is 5 as 10 and the total number of blocks is 5 as described in the attached table. The balanced in randomization allocation method for the participants in the randomized controlled clinical trial study is the effect of receiving memantine (group A)and placebo (group B)in reducing fatigue. Data will be analyzed in spss software version 23,using descriptive tests such as mean and standard deviation(for continious quantitative variables such as age)and number and percentage (for qualitative/nominal variables such as gender).
The data are analyzed by independent test to check the relationship between quantitative variables between two chi-square to check the relationship between qualitative variables between two groups. A statistically significant level of 5%is considered.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are assigned to two treatment groups A and B using the method of random blocks (Balance block randomization).
Balanced randomization allocation method for participants in a randomized controlled clinical trial study on the effect of receiving memantine (group A) and placebo (group B) in reducing fatigue
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bo Ali St. Bo Ali Sina Hospital
City
Qazvin
Province
Qazvin
Postal code
3413786165
Approval date
2023-12-26, 1402/10/05
Ethics committee reference number
IR.QUMS.REC.1402.276
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Examining the degree of fatigue based on the Modified Fatigue Impact Scale questionnaire
Timepoint
Comparison of fatigue before and 3 months after starting memantine and placebo
Method of measurement
Modified Fatigue Impact Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:Memantine 5 mg tablets by Hacim company .First daily for a week,then one every 12 hours for 3 months and orally. This drug is a competitive NMDA glutamate antagonist.
Category
Treatment - Drugs
2
Description
Control group:Vitamin B1 100 mg tablets by Hacim company.First daily for a week , then one every 12 hours for 3 months and orally.This medicine is a water-soluble vitamin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Fateme Jafari Chamandani
Street address
But Ali St
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fatemejafari78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
But Ali St
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fatemejafari78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Jafari Chamandani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Bu Ali St ، Bu Ali Hospital
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fatemejafari78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Jafari Chamandani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Bu Ali St. Bu Ali Hospital
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fatemejafari78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Jafari Chamandani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Bu Ali St.Bu Ali Hospital
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fatemejafari78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no customer information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available