General Objective:Evaluation of the Effect of Fingolimod on fatigue and depression in patients with Multiple Sclerosis. Study Design:Single arm study(before and after). Main Inclusion Criteria:18-50 years of age; relapsing remitting multiple sclerosis; disease must not be in its acute phase. Main Exclusion Criteria:Any underlying pulmonary,hepatic,renal or orthopedic disorder; EDSS score>5.5; natural events causing depression happen to the patient during follow up period. Target sample size:40. Fatigue Severity Scale and Beck's depression questionare at 0,3 and 6 month intervals must be obtained from the patients.Study outcomes:Effects of the Fingolimod on degree of fatigue and depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407018323N11
Registration date:2016-01-23, 1394/11/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-23, 1394/11/03
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the Effect of Fingolimod on Fatigue and depression in patients with Multiple Sclerosis
Public title
The evaluation of the Effect of Fingolimod on Fatigue and depression in patients with M.S
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age 18-50 years; definite M.S confirmed by neurologist with relapsing remitting type; disease must be in remission; at least one month after corticostroid therapy; follow up shouldbe possible and patients must be reachable. exclusion criteria: any underlying pulmonary,hepatic,renal or orthopedic; EDSS score>5.5; during follow up events that affect depression happen to the patients.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
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
Deputy of Research and Technology of Kermanshah University of Medical Sciencesarch and technology
Street address
Building number 2, Kermanshah University of Medical Sciences,shahid beheshti bulevard
City
Kermanshah
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
45249
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 severity
Timepoint
before intervention,3 months after initiation of intervention,6 months after initiation of intervention
Method of measurement
fatigue severity scale
2
Description
degree of depression
Timepoint
before intervention,3 months after initiation of intervention,6 months after initiation of intervention
Method of measurement
beck standard questionare
Secondary outcomes
1
Description
Liver enzymes concentrations
Timepoint
Before initiation of study,every month for the first 3 months,then every 3 months so on
Method of measurement
Liver function test
2
Description
Lymphositic count
Timepoint
Before initiation of study,every month for the first 3 months,then every 3 months after
Method of measurement
CBD-diff
Intervention groups
1
Description
Fingolimode,0.5 mg,once daily,oral,for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology ward,Kermanshah Emam Reza grand hospital
Full name of responsible person
Faezeh Nalchi
Street address
Kermanshah Emam Reza grand hospital, Daneshgah street, Shahid Shiroodi BLV
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Kermanshah University of Medical Sciences
Full name of responsible person
Hamzehee Kourosh
Street address
Building number 2, Kermanshah University of Medical Sciences,shahid beheshti bulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences, medical faculty
Full name of responsible person
Faezeh Nalchi
Position
medical doctor(PHD)/neurology resident
Other areas of specialty/work
Street address
school of medicine, Daneshgah street, Shahid Shiroodi bulevard
City
Kermanshah
Postal code
6714869914
Phone
+98 834274620
Fax
Email
mcollege@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, medical faculty
Full name of responsible person
Razazian Nazanin
Position
medical doctor,neurologist
Other areas of specialty/work
Street address
school of medicine, Daneshgah street, Shahid Shiroodi bulevard