The aim of this study is the assessment of evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis, over a 12 months period. Relapsing-Remitting Multiple Sclerosis patients aged between 18-50 years and Expanded Disability Status Score (EDSS) between 0-5.5 will be included. This study will be undertaken in 11 centers in Iran by presentation of 309 patients. Subjects who fulfill the eligibility criteria will be receive an oral capsule Fingolimod0.5 mg per day (made in Osvah Pharmaceutical Company). Study drug will be given orally at the first day in specialized center under supervision of a trained physician and nurse and the patient will be observed for at least 6 hours before discharge. The patient will receive the drug for the next two weeks and will be trained to use the drug for the rest of study. Subsequent dose will be taken at home. The patient will be visited every two weeks for the first month and then every month for the next 3 months and then every two months for eight months. In each visit adverse events, relapse rates and EDSS score will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112267419N4
Registration date:2012-09-07, 1391/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-07, 1391/06/17
Registrant information
Name
Naghmeh Hadidi
Name of organization / entity
Osvah pharmaceutical company
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 1066
Email address
n.hadidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Osvah Pharmaceutical Company , Tehran University of Medical Sciences
Expected recruitment start date
2012-08-21, 1391/05/31
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis
Public title
Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1.Patients with Relapsing- Remitting Multiple Sclerosis (MS) based on McDonald's Criteria (2010)
2. Age between 18-50 years old
3.Expanded Disability Status Scale (EDSS) 0- 5.5
4. Negative pregnancy test at baseline
5.Signing consent form
6. History of Chicken pox, VZV vaccination or positive antibody.
7. At least one documented relapse during one year prior to study while on first line disease modifying therapies.
8. No relapse during the last 30 days.
Exclusion Criteria :
1.Secondry or primary progressive MS
2.History of a chronic disease other than MS
3. History or presence of malignancy
4. Macular edema at onset
5. Active bacterial, fungal or viral infection
6. Treatment with corticosteorids (IV) during the past 30 days
7. Patients who have been previously treated with cyclophosphamide and mitoxantrone
8.Patients who have been treated with immunoglubulins or monoclonal antibodies during the past six months
9. Patients who have been treated with azothioprine or methtroxate during the past six months
10. Patients who have been treated with beta- Interferon or GA during the past 3 months
11.Medically Unstable patient according to site physician
12. Patient with history of syncope
13. History of cardiac arrest, heart failure, recurrent symptomatic bradycardia or ischemic heart disease
14. Abnormal Electro Cardio Gram (ECG) (Block, QT interval more than 440 milliseconds on screening ECG
15. Hypertension not controlled by prescribed medications
16.Patients with severe respiratory disease, Active pulmonary disease, Tuberculosis except successful treatment or prophylactic treatment after positive purified protein derivative (PPD)
17. Lost to follow up more than 3 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
309
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Vice chancellor for research ,Tehran University of Medical Sciences, Qods Street , Keshavarz Boulevard .
City
Tehran
Postal code
-
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
-
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Disseminated Multiple Sclerosis
Primary outcomes
1
Description
Relapse Rate
Timepoint
Before intervention and every month after intervention
Method of measurement
Physical examination done by neurologist and Expanded Disability Status Scale (EDSS)
Secondary outcomes
1
Description
Expanded Disability Status Scale
Timepoint
Before intervention and every month after intervention
Method of measurement
Physical examination done by neurologist based on revised Mc-Donald (2010)
2
Description
Number and size of plaques and their enhancement
Timepoint
Before intervention and every six months after intervention
Method of measurement
Magnetic resonance Imaging ( MRI )
Intervention groups
1
Description
fingolimod capsule, chemical formulation FTY -720 , (0.5 mg/ day, oral , every day) for 12 months ,made in Osvah Pharmaceutical Company in Islamic Republic Of Iran, generic name Cap. Fingolide
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sina Hospital,before Hasan abad Square , Imam Khomeini Street
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Hossein Harirchian
Street address
The end of Keshavarz Boulevard , Vali Asr Square , Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr. Hosein Pakdaman
Street address
Makhsoos Street , Qazvin Square , South Karegar Avenue , Tehran
City
Tehran
4
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr.Nahid Beladi Moghaddam
Street address
Madani Avenue , Tehran
City
Tehran
5
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Masoud Etemadifar
Street address
Safeh Boulevard ,Aghareb Parast Avenue , Isfahan
City
Isfahan
6
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Dr. Vahid Shaygannejad
Street address
Kashani Street , Isfahan
City
Isfahan
7
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr. Ali Reza Nikseresht
Street address
Namazi Square, Shiraz
City
Shiraz
8
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Mohsen Foroughipour
Street address
Ahmadabad Avenue, Dr. shariati Square, Mashhad
City
Mashhad
9
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Nastaran Majdi nasab
Street address
Golestan Ahwaz
City
Ahwaz
10
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr. behnaz sedighi
Street address
Farabi Stree , Kerman
City
Kerman
11
Recruitment center
Name of recruitment center
Imam Reza Hopital
Full name of responsible person
Dr. Hormoz Ayromlou
Street address
Golgasht Street , Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Osvah Pharmaceutical Company
Full name of responsible person
Dr. Abbas Kebriaee zadeh
Street address
5th floor - Number112 - Western Hafezi street - Farahzadi Avenue - Shahrake gharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Osvah Pharmaceutical Company
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research ,Tehran University of Medical Sciences
Full name of responsible person
-
Street address
Vice chancellor for research ,Tehran University of Medical Sciences, Qods Street, Keshavarz Boulevard.
City
Tehran
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 ,Tehran University of Medical Sciences
Proportion provided by this source
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
Osvah Pharmaceutical Company
Full name of responsible person
Dr. Naghmeh Hadidi
Position
PhD Graduate of Pharmaceutics /The head of market researches and clinical trials department
Other areas of specialty/work
Street address
5th floor - Number 112 - Western Hafezi street - Farahzadi Avenue - Shahrake gharb
City
Tehran
Postal code
-
Phone
+98 21 2213 1066
Fax
-
Email
hadidi@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Mohammad Ali Sahraian
Position
Neurologist-MS Fellowship/Associate Professor
Other areas of specialty/work
Street address
Sina Hospital, before Hasan abad Square , Imam Khomeini Street.
City
Tehran
Postal code
-
Phone
+98 21 6634 8571
Fax
+98 21 6634 8570
Email
msahrai@sina.tums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Osvah Pharmaceutical Company
Full name of responsible person
Dr. Naghmeh Hadidi
Position
PhD Graduate of Pharmaceutics /The head of market researches and clinical trials department
Other areas of specialty/work
Street address
5th floor- Number112- Western Hafezi street - Farahzadi Avenue - Shahrake gharb
City
Tehran
Postal code
-
Phone
+98 21 2213 1066
Fax
-
Email
hadidi@gmail.com n.hadidi@sbmu.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)