Imatinib Treatment for Secondary Progressive Multiple Sclerosis: A Randomized Control Trial Study Assessing Clinical and Radiological Responses and adverse effects in comparison with Novanterone
Objectives: Imatinib Treatment for Secondary Progressive Multiple Sclerosis: A Randomized Control Trial Study Assessing Clinical and Radiological Responses and adverse effects in comparison to Novantrone.
Design: Multiple sclerosis is a chronic degenerative autoimmune disorder which leads to demyelinating inflammation of white matter of central nervous system. Because of our incomplete knowledge of its pathogenesis, despite of extensive researches in this field there is no definite cure for multiple sclerosis. Recent investigations show that protein kinase inhibitors such as Imatinib can reduce macrophage activation and astrocytosis via inhibition of Tyrosine Kinase CSF-1 Receptor and PDGFRs related signaling. These pathways play crucial role in the pathogenesis of autoimmune diseases including multiple sclerosis. There upon, it is suggested that these drugs may have beneficial therapeutic effect in these disorders. According to lesser adverse effects of these drugs in comparison to FDA-approved treatment for SPMS such as Novantrone, confirmation of this idea can be an important step in treatment of this disabling disease.
Conduct and setting: This project is a one-centric double-blind randomized control clinical trial.
Interventions: After verifying the consensus form, Case group will receive Imatinib (400 mg PO daily), and control group will receive Novantrone according to accepted guidelines.
Participants including major eligibility criteria: Inclusion criteria: SPMS patients with relapse. Exclusion criteria: History of chronic hematologic, renal, liver or infectious diseases; Pregnancy; history of cancer especially breast tumor;
Major outcome: Number of relapse and EDSS changes and number of new plaques in MRI during six months; reported adverse effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210231584N3
Registration date:2012-11-14, 1391/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-14, 1391/08/24
Registrant information
Name
Mohammad Hossein Harirchian
Name of organization / entity
Tehran University of Medical Science, Iranian Center of Neurological Research
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 3731
Email address
harirchm@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Imatinib Treatment for Secondary Progressive Multiple Sclerosis: A Randomized Control Trial Study Assessing Clinical and Radiological Responses and adverse effects in comparison with Novanterone
Public title
The evaluation of therapeutic effects and adverse effects of Imatinib in Secondary Progressive Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: SPMS patients with relapse; EDSS between 3 and 5; age between 18 and 40
Exclusion criteria: History of other autoimmune disorder or chronic hematologic, renal, liver or infectious diseases; Pregnancy; lactation; History of HIV and Hepatitis; History of cancer especially breast tumor; History of recent herpes zoster infection; History of cytotoxic drugs consumption during recent three months; History of high dose corticosteroid during recent two months.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
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
Ethics committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, 5th floor, Ghods St, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
91-02-54-18123-66824
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis (MS), also known as
Primary outcomes
1
Description
Clinical signs and symptoms
Timepoint
every one month
Method of measurement
Number of relapses during six months, EDSS changes
2
Description
adverse effect
Timepoint
every one month
Method of measurement
biochemical test, clinical examination
Secondary outcomes
1
Description
Number of new plaques in MRI
Timepoint
six months
Method of measurement
Brain MRI with and without Gad
Intervention groups
1
Description
Case group receives Imatinib 400 mg daily (PO)
Category
Treatment - Drugs
2
Description
Control group will receive Novanterone according to accepted guidelines
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Center of Neurological Researches
Full name of responsible person
Dr Mohammad Hossein Harirchian
Street address
Iranian Center of Neurological Researches, Imam khomeini Hospital,Blvd Keshavarz, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Fotuhi
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Ghods Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
91-02-54-18123
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Harirchian
Position
Professor of Neurology
Other areas of specialty/work
Street address
Iranian Center of Neurological Researches, Imam Khomeini Hospital, Blvd Keshavarz, Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2424
Fax
+98 21 6119 2424
Email
harirchm@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Harirchian
Position
Professor of neurology
Other areas of specialty/work
Street address
Iranian Center of Neurological Researches, Imam Khomeini Hospital, Blvd Keshavarz, Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2424
Fax
Email
harirchm@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Bahaadin Siroos
Position
Resident of Neurology
Other areas of specialty/work
Street address
Iranian Center of Neurological Researches, Imam Khomeini Hospital, Blvd Keshavarz, Tehran, Iran.
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 8899
Fax
Email
bsiroos@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)