The assessment of effect of Cinnovex, Rebif and Betaferon on serum level of brain-derived neurotrophic factor in multiple sclerosis patients referring to neurology department of Ahwaz Golestan hospital.
(1)Objectives:The assessment of the effect of Cinnovex, Rebif and Betaferon on serum levels of brain-derived neurotrophic factor. (2)Design:sampling of all newly diagnosed multiple sclerosis patients referring to neurology department of Ahvaz Golestan hospital, according to inclusion and exclusion criteria, up to 55 cases.(3)Setting and conduct:serum levels of brain-derived neurotrophic factor and expanded disability status scale of new diagnosed multiple sclerosis patients will be measured at the time of diagnosis and three months after description of Cinnovex, Rebif and Betaferon, and results will be compared statistically. (4)Participants:55 cases. Major inclusion criteria:no history of receiving Interferons, Mitoxantrone or Cyclophosphamide for any reason؛ and expanded disability status scale between 0 and 5.5. Major exclusion criteria:change in patient's medication regimen during the study؛ and lack of access to patient. (5)Intervention:vial Cinnovex 30micrograms intramuscular weekly, or vial Rebif 44micrograms three times a week, or vial Betaferon 250micrograms every other day. (6)Main outcome measure (variable):serum brain-derived neurotrophic factor level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013073114234N1
Registration date:2013-09-14, 1392/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-14, 1392/06/23
Registrant information
Name
Shahram Tarahomi
Name of organization / entity
Ahvaz Jondishapoor university
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
tarahomi.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jondishapur University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of effect of Cinnovex, Rebif and Betaferon on serum level of brain-derived neurotrophic factor in multiple sclerosis patients referring to neurology department of Ahwaz Golestan hospital.
Public title
The assessment of effect of Cinnovex, Rebif and Betaferon on serum level of brain-derived neurotrophic factor in multiple sclerosis patients referring to neurology department of Ahwaz Golestan hospital.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(1)Newly diagnosed multiple sclerosis patients (documented in neurology department of Ahvaz Golestan hospital); (2)No history of receiving Interferons, Mitoxantrone or Cyclophosphamide for any reason; (3) Expanded disability status scale between 0 and 5.5; (4)No involvement to other neurologic or autoimmune diseases.
Exclusion criteria:
(1)Patient’s unwillingness to continue participation in the survey; (2)Change in patient's medication regimen during the study; (3)Lack of access to patient (death, migration).
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
N/A
Randomization description
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-15794
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
Eth-652
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Type of medication
Timepoint
At the beginning of survey and three months after first sampling
Method of measurement
Nominal(Cinnovex, Rebif, Betaferon)
2
Description
serum level of brain-derived neurotrophic factor
Timepoint
At the beginning of survey and three months after first sampling
Method of measurement
Picogram per milliliter
3
Description
Expanded Disability Status Scale (EDSS)
Timepoint
At the beginning of survey and three months after first sampling
Method of measurement
Number from 0 up to 10
Secondary outcomes
1
Description
Age
Timepoint
At the beginning of survey
Method of measurement
Year
2
Description
Sex
Timepoint
At the beginning of survey
Method of measurement
Nominal (male-female)
Intervention groups
1
Description
Vial Cinnovex, 30microgram, Intamuscular, weekly, for 3months
Category
Treatment - Drugs
2
Description
Vial Rebif, 44microgram, Subcutaneous, 3times a week, for 3 months
Category
Treatment - Drugs
3
Description
Vial Betaferon, 250microgram, Subcutaneous, every other day, for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Shahram Tarahomi, MD
Street address
Nosrat St, Golestan Blv.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi, MD
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahram Tarahomi, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
tarahomi.sh@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasraran Madjdinasab, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
n.madjdinasab@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahram Tarahomi, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
tarahomi.sh@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)