The aim of this study is to compare the effect of mitoxantrone and mitoxantrone plus methylprednisolone on Progressive MS. Our study (a randomized clinical trial) will be performed on 70 patients suffering from progressive MS in two parallel groups. The first group (35 patients) will receive 20 mg mitoxantrone plus 500 mg methylprednisolone monthly for 6 months. The second group (35 patients) will receive the same dose of mitoxantrone plus 100 CC of 5% dextrose water monthly for 6 months. Two indices will be measured before the study, end of drug administration and 6 months after drug prescription completion: Expanded Disability Status Scale (EDSS) and MRI’s plaque numbers. The results of the physical examination and laboratorial tests of both groups will be compared before and after treatment completion and 6 months after the trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107145943N3
Registration date:2011-07-22, 1390/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-22, 1390/04/31
Registrant information
Name
Abolghasem Rahimdel Meibidi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4001
Email address
rahimdel30142@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Yazd University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Mitoxantrone and Mitoxantrone plus Methylprednisolone on Progressive Multiple Sclerosis
Public title
Evaluation the effect of adding methylprednisolone to mitoxantrone on progressive multiple sclerosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of progressive MS, age between 20 to 50
Exclusion criteria: Age below 20 or above 50, Immune deficiency, cancer, Pregnancy or breast feeding, Renal or heart failure, Leukopenia during the injection (the reduction of neutrophils to less than 1500/ml), having received corticosteroids within 6 months before the trial
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Shahid baahonar Square
City
Yazd
Postal code
Approval date
2010-02-22, 1388/12/03
Ethics committee reference number
127469/1/17/پ
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
MRI plaque numbers
Timepoint
6 months and 1 year after the intervention
Method of measurement
Based on MRI imaging
2
Description
Expanded Disability Status Scale (EDSS)
Timepoint
6 months and 1 year after the intervention
Method of measurement
Based on definit idex
Secondary outcomes
empty
Intervention groups
1
Description
Control group: mitoxantrone 20 mg as well as methylprednisolone 500 mg monthly for 6 consecutive months
Category
Treatment - Drugs
2
Description
Intervention group: mitoxantrone 20 mg monthly for 6 consecutive months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid sadoughi hospital
Full name of responsible person
Ali Mellat Ardekani
Street address
Shahid sadoughi hospital, Safaaieh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ezoddini
Street address
Shahid bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd Univesity of Medical Sciences
Full name of responsible person
Ali Mellat Ardekani
Position
Assistant Professor
Other areas of specialty/work
Street address
Safaayeih
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
Ali_mellat@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abolghasem Rahimdel
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid sadoughi hospital, Safaayieh
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
rahimdel30142@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Mellat Ardekani
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid sadoughi hospital, Safaayieh
City
Yazd
Postal code
Phone
Fax
Email
ali_mellat@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)