A clinical trial to compare the effectiveness of dimethyl fumarate in multiple sclerosis patients before and after intervention.
Design
This clinical trial with a before and after treatment design of 40 patients with multiple sclerosis were assigned base on community-based setting.
Settings and conduct
The study population will be selected from the patients with multiple sclerosis referring to Multiple Sclerosis Central Committee, Mashhad University of Medical Sciences, Mashhad, Iran, and will be administered dimethyl fumarate for treatment.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients with relapsing-remitting multiple sclerosis.
Exclusion criteria: having a blood and liver failure; discontinuation of treatment cause of disruption in laboratory tests.
Intervention groups
The intervention group will receive 240 mg dimethyl fumarate twice a day for one year.
Main outcome variables
Number and severity of attacks based on expanded disability status scale (EDSS) score and the number of magnetic resonance imaging (MRI) lesions based on brain MRI before and one year after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042439N1
Registration date:2019-02-02, 1397/11/13
Registration timing:prospective
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Sahar Gazeran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
gazerans941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of dimethyl fumarate in multiple sclerosis patients before and after intervention.
Public title
The reduction in the number of attacks in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with relapsing-remitting multiple sclerosis
Exclusion criteria:
History of blood diseases
Liver failure
Discontinuation of treatment cause of disruption in laboratory tests
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2017-11-08, 1396/08/17
Ethics committee reference number
IR.MUMS.fm.REC.1396.475
Health conditions studied
1
Description of health condition studied
Multiple sclerosis patients
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Number and severity of attacks
Timepoint
Before and one year after intervention
Method of measurement
Expanded disability status scale (EDSS) score
Secondary outcomes
1
Description
The number of magnetic resonance imaging (MRI) lesions
Timepoint
Before and one year after intervention
Method of measurement
Brain MRI
Intervention groups
1
Description
Intervention group: The intervention group will receive 240 mg dimethyl fumarate twice a day for one year.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Central Committee
Full name of responsible person
Sahar Gazeran
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Gazerans941@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
913753459
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Gazeran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Gazerans941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Gazeran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Gazerans941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Gazeran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Gazerans941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Sahar Gazeran provides the analysis code to the applicants via email: Gazerans941@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.