Efficacy evaluation of dalfampiridine on MS fatigue
Efficacy evaluation of Amantadine on MS fatigue
evaluation of dalfampiridine and amatadine tolerabilty
Evaluation of Quality of life following dalfampiridine and amantadine administration
Design
A randomized parallel group clinical trial with blinded outcomes assessment of 80 patients. Randomization will be done according permuted block way.
Settings and conduct
This study is a randomized and double blind clinical trial will be conducted at MS clinic in Ibne Sine hospital in patients with fatigue of MS. Principle investigators, researcher and participants will be blinded.
Participants/Inclusion and exclusion criteria
Adult patients ware aged more than 18 years with MS according Mcdonald criteria 2017 and have FATIGUE SCORE OF MIFS›33 WILL BE RECRUITED.
Exclusion criteria:
severe depression, hypothyroidism, Severe anemia ( Hb‹ 9 g/dl), pregnancy or breast feeding, IHD OR cardiovascular disease, real insufficiency, MS exacerbation within one months before, uncontrolled blood pressure (more than 160/100 mm Hg), co-administration of effective drugs on fatigue, alcohol, recreational or substance abuse hisory, MAOIs use, history of narcolepsy, psychosis and seizure.
Intervention groups
Intervention: dalfampiridine 10 mg q 12 hour for 8 weeks
Control: Amantadine 100 mg q 12 hour for 8 weeks
Main outcome variables
Fatigue and quality of life according improvement to MFIS and quality of life questionnaire and tolerability of therapeutic regimens.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190804044429N2
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Monireh Ghazaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 6864
Email address
ghazaeianm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of amantadine and dalfampridine efficacy in multiple sclerosis patients with fatigue
Public title
Amantadine and dalfampiridine effects on multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients were aged more than 18 years
Patients with multiple sclerosis according to Mcdonald criteria 2017 and EDSS less than 5.5
MS patients with at least fatigue score of 33 according to MFIS
Exclusion criteria:
Severe depression
Hypothyroidism
Severe anemia ( Hb‹ 9 g/dl)
Pregnancy or breast feeding
Ischemic heart disease or cardiovascular disease
Renal insufficiency
MS exacerbation within 30 days before
Uncontrolled blood pressure (BP more than 160/100 mm Hg)
use of other effective treatment on fatigue
Alcohol, recreational and substance abuse history
Monoamine oxidase inhibitors (MAOIs) use
Narcolepsy history
Psychosis history
Seizure history
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A master randomization schedule was prepared by a person not associated with the study who used permuted blocks of random numbers. The medicine bottles and identical placebo were prepared by a pharmaceutical manufacturer Randomization was incorporated in the serially numbered bottles containing drug or placebo by person not involved with the study according to random numbers. The number of the bottle corresponded with the number of the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and principle investigator and statistic staff will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Science
Street address
Ibn Sina Hospital, Pasdaran Blvd, Sari, Mazandaran.
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.MAZUMS.REC.1399.325
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 improvement
Timepoint
At weeks 4, and 8
Method of measurement
MFIS questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
At weeks 4 , 8
Method of measurement
SF-36 Questionnaire
2
Description
Tolerable of therapeutic regimen
Timepoint
Weekly
Method of measurement
History taking
Intervention groups
1
Description
Intervention group: dalfampridine 10 m q12 hour for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Amantadine 100 mg q 12 hour for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina hospital
Full name of responsible person
Monireh Ghazaeian
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Joybar 3way , Sari, Iran.
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3448 4800
Fax
+98 11 3335 2725
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of trial including analysis data and method of the study
When the data will become available and for how long
At the time of publication, the data of the study will be available.
To whom data/document is available
academic researchers, medical team and scientific institutes
Under which criteria data/document could be used
For research and practical purposes
From where data/document is obtainable
Dr. Monireh Ghazaeian, Faculty of pharmacy, Mazandaran University of Medical Sciences.
What processes are involved for a request to access data/document
The scientific responsible person of the study will reply to the request within 10 days.