Objective: Effects of Memantine on fatigue in Multiple sclerosis (MS) patients.
Study design: It is a Randomized; double-blind; placebo-controlled; single-center; and Phase 1 clinical trial. Randomization of the study is stratified block randomization (using blocks of 4) based on sex.
Study population: They are patients with definite diagnosis of MS based on diagnostic McDonald criteria that receive the standard treatment for MS and have been referred from clinic of neurology of Imam Khomeini Hospital in 1395.
Inclusion criteria: A history of multiple sclerosis (MS) for more than one year; Relapsing Remitting (RR) type of MS; Subjective fatigue (grade 3 or 4 of fatigue based on questionnaires); Age of 55-20 years; Expanded Disability Status Scale (EDSS): 0-5; Consent to participate in the study.
Exclusion criteria: Use of Modafinil, Ritalin or Amantadine; A history of seizure and kidney disease; Taking selective serotonin reuptake inhibitors (SSRI); Other types of diseases.
Sample Size: 64 patients (32 patients in each group).
Intervention: intervention group receive 10 mg daily (1 tablet) for one week and then 20 mg daily (2 tablets) until the end of 3 months of study; control group receive 1 tablet of placebo for one week and then 2 tablets of placebo until the end of 3 months of study.
Primary outcome: fatigue.
Secondary outcomes: Depression; cognitive status and physical disability.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121231362N1
Registration date:2017-01-03, 1395/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Mohammad Hossein Harirchian
Name of organization / entity
Iranian center of neurological research
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8899
Email address
harirchm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Center of Neurological Research
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2017-01-29, 1395/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Memantine on fatigue in patients with Multiple sclerosis: A double-blind randomized controlled clinical trial
Public title
Effects of Memantine on fatigue in patients with Multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A history of multiple sclerosis (MS) for more than one year; Type of MS was Relapsing Remitting (RR); Subjective fatigue (grade 3 or 4 fatigue based on questionnaires); Age of 20-55 years; Expanded Disability Status Scale (EDSS): 0-5; Consent to participate in the study.
Exclusion criteria: Use of Modafinil, Ritalin or Amantadine; A history of seizure and kidney disease; Taking selective serotonin reuptake inhibitors (SSRI); Other types of diseases.
Age
From 20 years old to 55 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Blocking design based on sex
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.808
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
fatigue
Timepoint
before intervention, 3 months after start of intervention
Method of measurement
MFIS Questionnaire
Secondary outcomes
1
Description
depression
Timepoint
before intervention, 3 months after start of intervention
Method of measurement
Beck II questionnaire
2
Description
cognitive disorders
Timepoint
before intervention, 3 months after start of intervention
Method of measurement
MACFIMS test
3
Description
disability
Timepoint
before intervention, 3 months after start of intervention
Method of measurement
EDSS test
Intervention groups
1
Description
Intervention group: memantine, 10 mg oral tablet, one per day for the first week and then twice a day for three months
Category
Treatment - Drugs
2
Description
Control group: placebo (exactly the same as the intervention group), oral tablet, one per day for the first week and then twice a day for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Center of Neurological Research
Full name of responsible person
Mohammad hossein Harirchian
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Farzad Fatehi
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Grant name
----------------
Grant code / Reference number
-----------------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Center of Neurological Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Mohammad hossein Harirchian
Position
Neurologist
Other areas of specialty/work
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 6694 8899
Fax
+98 21 6658 1558
Email
harirchm@tums.ac.ir
Web page address
----------
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Mohammad hossein Harirchian
Position
Neurologist
Other areas of specialty/work
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 6694 8899
Fax
+98 21 6658 1558
Email
harirchm@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Sama Bitarafan
Position
Researcher, MD& PhD
Other areas of specialty/work
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 6694 8899
Fax
+98 21 6658 1558
Email
Bitarafan@sina.tums.ac.ir; Bitarafans@gmail.com
Web page address
----------------
Sharing plan
Deidentified Individual Participant Data Set (IPD)