Protocol summary

Study aim
To assess the effect of Ondansetron versus Amantadine on fatigability in patients with multiple sclerosis
Design
This is a randomized clinical trial, phase II, in which 104 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with multiple sclerosis who will refer to Sina Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 65 years; Multiple sclerosis; Complaining of fatigability The ability to walk without assistance for at least 100 meters; FSS score of equal to or greater than 28 Exclusion criteria: Systemic disease such as cardiovascular diseases, infection, thyroid disease, or vasculitis
Intervention groups
Intervention group: Tablet Ondansetron 4 mg twice a day for 4 weeks Control group: Capsule Amantadine 100 mg twice a day for 4 weeks
Main outcome variables
Assessing the fatigability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N250
Registration date: 2018-11-20, 1397/08/29
Registration timing: registered_while_recruiting

Last update: 2018-11-20, 1397/08/29
Update count: 0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Ondansetron versus Amantadine on fatigability in patients with multiple sclerosis: a randomized clinical trial
Public title
Effects of Ondansetron versus Amantadine on fatigability in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years; Multiple sclerosis; Complaining of fatigability The ability to walk without assistance for at least 100 meters; FSS score of equal to or greater than 28
Exclusion criteria:
Systemic disease such as cardiovascular diseases, infection, thyroid disease, or vasculitis
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.UMSHA.REC.1397.500

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
Assessing the fatigability
Timepoint
Before and 4 weeks after treatment
Method of measurement
Using a standard questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tablet Ondansetron 4 mg twice a day for 4 weeks
Category
Treatment - Drugs

2

Description
Control group: Capsule Amantadine 100 mg twice a day for 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Ashkan Karvan
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
karevanashkan2@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ashkan Karvan
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
karevanashkan2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Khazaei
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
khazaeimojtaba@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Loading...