This is a clinical trial study aimed at the investigation of the effect of methylprednisolon plus mitoxantrone in the treatment of progressive multiple sclerosis in Yazd province. The patients will be assigned to receive 20mg mitoxantrone and 500mg methyl prednisolone or 20mg mitoxantrone and 100cc dextrose water 5% (6 monthly injections). Cranial nerves examination, muscular power at proximal and distal portion according to scale from 0 to 5, cerebellum examination, and the number of plaques will be done before and after the study and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012245393N1
Registration date:2011-04-05, 1390/01/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-05, 1390/01/16
Registrant information
Name
Hamid Reza Soltani.G
Name of organization / entity
Yazd Islamic Azad University, Medical Society of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 35 1623 1817
Email address
hrsgmed@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadooghi University of Medical Sciences and Health Services
Expected recruitment start date
2010-06-01, 1389/03/11
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of methylprednisolon plus mitoxantrone in the treatment of progressive multiple sclerosis
Public title
The effect of methylprednisolon plus mitoxantrone in the treatment of progressive multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with progressive multiple sclerosis, Informed consent, age between 20-50 year
Exclusion criteria: HIV+ patients, cancer, heart failure, immunodeficiency patients, patients with neutrophil count less than 1500
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:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Sadooghi Medical University
Street address
Central Organization of Shahid Sadooghi Medical University, Bahonar Sq, Yazd
City
Yazd
Postal code
8916978477
Approval date
2011-02-21, 1389/12/02
Ethics committee reference number
پ 127469/1/17
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
Expanded Disability Status Scale
Timepoint
6 months after the beginning of study
Method of measurement
by a checlkist, standard criteria
2
Description
muscular power after treatment
Timepoint
6 months after the beginning of study
Method of measurement
physical examination
3
Description
cerebellum symptoms
Timepoint
6 months after the beginning of study
Method of measurement
physical examination
4
Description
MRI findings (number of lesions) after treatment
Timepoint
6 months after the beginning of study
Method of measurement
MRI
5
Description
cranial nerves involvement
Timepoint
6 months after the beginning of study
Method of measurement
physical examination
Secondary outcomes
1
Description
heartburn
Timepoint
6 months after the beginning of study
Method of measurement
ask from patients
2
Description
vomitting
Timepoint
6 months after the beginning of study
Method of measurement
ask from patients
3
Description
anorexia
Timepoint
6 months after the beginning of study
Method of measurement
ask from patients
4
Description
hair loss
Timepoint
6 months after the beginning of study
Method of measurement
ask from patients
5
Description
leukopenia
Timepoint
6 months after the beginning of study
Method of measurement
through hematologic test CBC
Intervention groups
1
Description
Intervention group: 20mg Mitoxantrone plus 500 mg methylprodnisolon during 6 months follow up
Category
Treatment - Drugs
2
Description
Control group: 20mg mitoxantrone (injection) and 100cc dextrose water 5% (control) with six months follow up
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadooghi University of Medical Sciences and Health Services
Full name of responsible person
Dr Aabolghasem Rahimdel
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health Services
Full name of responsible person
Dr fatemeh ezaddini
Street address
Research deputy, Central Organization, Bahonar sq, yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadooghi University of Medical Sciences and Health Services
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
Scientific Soceity of Medicine, Islamic Azad Univerisity branch Yazd
Full name of responsible person
Hamid Reza Soltani
Position
Student of medicine
Other areas of specialty/work
Street address
Scientific Society of Medicine Office, Islamic Azad University branch Yazd, Yazd, Iran
City
Yazd
Postal code
Phone
+98 913 351 8033
Fax
Email
hrsgmed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health Services
Full name of responsible person
Abolghasem Rahimdel
Position
Assistant Professor of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Shahid Sadooghi Hospital, Yazd
City
Yazd
Postal code
Phone
+98 913 153 6780
Fax
Email
rahimdel30142@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Scientific Soceity of Medicine, Islamic Azad University branch Yazd
Full name of responsible person
Hamid Reza Soltani.G
Position
Student of Medicine
Other areas of specialty/work
Street address
City
Yazd
Postal code
8916783189
Phone
Fax
+98 35 1821 4818
Email
hrsgmed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)