Determining and comparing the physical, cognitive and psychological aspects of fatigue between the intervention and control groups in patients with multiple sclerosis before and after receiving the drug and placebo
Design
In the form of randomised clinical Trial, with intervention and control groups. parallel group randomised trial with double blinded postoperative care and outcome assessment. Sample size of 44 people in each group
Settings and conduct
To patients in the first group, the drug Fampridine (with brand name Dalfyra) 10 mg is given twice daily and the other group is given a placebo (in the form of tablets by cinnagen). This study is double blind and the patient and the facilitator do not know the type of drug given .
Participants/Inclusion and exclusion criteria
Patients with MS over the age of 18 who have not taken Dalfira for the past year.
Patients have not had an acute attack in the last 3 months.
Patients have EDSS below 7.
Patients are not allergic to the drug.
Patients do not have a kidney problem or a history of seizures
Intervention groups
Fampridine(Dalfyra brand name) 10 mg (the pharmaceutical company Cinnagen) given to patients in the intervention group twice daily and placebo drug control (in pill form by Cinnagen) is given as same.
Main outcome variables
The physical aspect of MFIS (modified fatigue impact scale) ;
Cognitive aspects of MFIS;
The psychosocial aspect of MFIS
MFIS total score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210429051129N1
Registration date:2021-06-07, 1400/03/17
Registration timing:prospective
Last update:2021-06-07, 1400/03/17
Update count:0
Registration date
2021-06-07, 1400/03/17
Registrant information
Name
Shirin Mavandadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 6033
Email address
sh.mavandadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Dalfyra (extended release Fampridine) in fatigue in multiple sclerosis patients
Public title
Efficacy of Dalfyra (extended release Fampridine) in fatigue in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with MS over the age of 18 who have not taken Dalfyra for the past year.
Patients have The Expanded Disability Status Scale (EDSS) below 7
Exclusion criteria:
Patients have a kidney problem or a history of seizures.
Patients who are allergic to this drug.
Patients who have had an acute attack in the last 3 months.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Patients are divided into two treatment groups A and B using Balance block randomization method, the size of each block is 4 and the total number of blocks is 11.
Balanced randomization allocation method for participants in a randomized controlled clinical trial study of the effect of receiving Dalfyra (group A) and placebo (group B) in reducing fatigue in patients with multiple sclerosis
Randomization unit: individual
Randomization tool: based on statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
These patients are divided into two groups based on random allocation: Dalfyra and placebo (11 blocks of 4).
Patients in the first group are given famperidine, brand name Dalfyra 10 mg (from cinnagen Pharmaceutical Company) twice a day, and the other group is given a placebo (in the form of tablets by cinnagen Company). This study is double blind and the patient and the executor of the project do not know the type of drug given.
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
Qazvin University - Bahonar Blvd- Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
1531534199
Approval date
2021-04-07, 1400/01/18
Ethics committee reference number
IR.QUMS.REC.1400.013
Health conditions studied
1
Description of health condition studied
Fatigue in patients with multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Fatigue score based on modified fatigue impact scale (MFIS) questionnaire
Timepoint
Both groups complete the Fatigue score based on modified fatigue impact scale (MFIS) questionnaire at the beginning of the study and three months later
Method of measurement
Based on the Fatigue score based on modified fatigue impact scale (MFIS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group are given Famperidine (Delfyra 10 mg ) (from Cinnagen Pharmaceutical Company) twice daily for three months.
Category
Treatment - Drugs
2
Description
Control group: The control group is given a placebo (in the form of tablets by Cinnagen Pharmaceutical Company) twice a day for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Boali Hospital
Full name of responsible person
Shirin Mavandadi
Street address
Boali Educational and Medical Center, Boali Ave, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6033
Fax
+98 28 3332 6033
Email
boali.hospital@qums.ac.ir
Web page address
http://hosbooali.qums.ac.ir/Portal/Home/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mohammad mahdi Emamjomeh
Street address
Qazvin University of Medical Science Department of Research and Technology , Mavadat Street, Shahid Behesti Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
memamjomeh@qums.ac.ir
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
Shirin Mavandadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Bouali Hospital, bouali ave, qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6033
Fax
Email
sh.mavandadi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shirin Mavandadi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Bouali Hospital, bouali ave, qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6033
Fax
Email
sh.mavandadi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shirin Mavandadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Bouali Hospital, bouali ave, qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6033
Fax
Email
sh.mavandadi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patient unidentifiable individuals data and the final clinical study report can be Released.
When the data will become available and for how long
Releasing after one year of publication of the study results
To whom data/document is available
Academic-scientific institutions
Under which criteria data/document could be used
The use of data and results is permitted for future scientific research.
From where data/document is obtainable
Receive data by email to the researcher
shirin. mavandadi@yahoo.com
sh.mavandadi@qums.ac.ir
What processes are involved for a request to access data/document