comparison of the effect of Fingolimode and Betaferon (high dose) in decreasing the symptoms and relapse rates of MS patients whose treatment with Betaferon (low dose) was failed.
This is a randomized blind clinical trial for comparing oral drug (Fingolimode) with high dose interferone (S.C) in treating symptoms and reduction of relapse rates in MS patients.50 patients with inclusion criteria who were under treatment of low dose Betaferon (Cinnovex.Avonex.Actovex) and have treatment failure. (more than one relapse during one year) will categorize in two randomized selected groups .we prescribe Fingolimode in 0.5 mg daily for first group and Betaferon (high dose) (Rebif.Actorif.Recigen) in second one through S.C every three days .patients will be evaluated through months 0.3.9.12.18 (5 visits after intervention) by neurologist who will not interfer in any parts of study and will not be aware of which patients will take which treatment. patients will analysis through E.D.S.S for surveying the intensity of disease or relapses.MRI will also be take through months 0 and 18.at last data will be analysed.
General information
Acronym
E.D.S.S
IRCT registration information
IRCT registration number:IRCT2015112025146N1
Registration date:2016-02-18, 1394/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Pedram Moeini
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3440 5907
Email address
pedrammoeini@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-27, 1393/08/05
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of Fingolimode and Betaferon (high dose) in decreasing the symptoms and relapse rates of MS patients whose treatment with Betaferon (low dose) was failed.
Public title
comparison of Fingolimode and Betaferon(high dose) in M.S treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:The most important one is MS patients who had treatment failure (relapsing rate more than one) under Betaferon ( low dose) ; patient acceptance; non immunosuppressive patient.
Exclusion criteria: noncooperative patient; death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Isfahan University of Medical Sciences
Street address
Hezar jarib street, Darvazeshiraz square
City
Isfahan
Postal code
Approval date
2015-01-22, 1393/11/02
Ethics committee reference number
394053
Health conditions studied
1
Description of health condition studied
M.S
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis
Primary outcomes
1
Description
Disability Status
Timepoint
befor intervention and 3.9.12.18 months after intervention
Method of measurement
Check list of E.D.S.S
2
Description
Relapse Numbers
Timepoint
0,3,9,12,18 months after intervention
Method of measurement
History and observation
Secondary outcomes
empty
Intervention groups
1
Description
Fingolimode 0.5 mg /day will orally prescribe 18 months for a subgroup of patients who had treatment failure with Betaferon (low dose) during last year.
Category
Treatment - Drugs
2
Description
Betaferon high dose s.c every 2 days will prescribe 18 months for the other subgroup of patients who had treatment failure during last year with Betaferon (low dose).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
St ZAHRA Hospital
Full name of responsible person
Pedram Moeini
Street address
Sofhe street, Hakim nezami Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Nematbakhsh
Street address
Hezar jarib street, Darvazeshiraz square
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Pedram Moeini
Position
Neurology Resident
Other areas of specialty/work
Street address
Hezar jarib street, Darvazeshiraz square
City
Isfahan
Postal code
Phone
00
Fax
Email
pmoeini@yahoo.com
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Pedram Moeini
Position
Neurology Resident
Other areas of specialty/work
Street address
Hezar jarib street, Darvazeshiraz square
City
Isfahan
Postal code
Phone
00
Fax
Email
pmoeini@yahoo.com
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Pedram Moeini
Position
Neurology Resident
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 913 114 7431
Fax
Email
pmoeini@yahoo.com
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)