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The evaluation of the efficacy and safety of oral fingolimod in relapsing remitting multiple sclerosis

Protocol summary

Summary
In order to investigate efficacy and safety of oral fingolimod in relapsing-remitting multiple sclerosis (RRMS), a clinical trial will be done for 3 months. Participants will be recruited from RRMS patients living in Kermanshah province, referred to Emam Raza hospital MS clinic in Kermanshah, who are eligible to the study inclusion and exclusion criteria, until study sample size of 60 cases is reached. After describing study goals to the patients and providing written informed consent, patients will be admitted to hospital for at least 6 hours to receive first dose oral fingolimod (0.5 mg fingolid ® capsules,Osve pharmaceuticals) to rule out probable bradycardia and heart block. During admission heart rate, blood pressure and electrocardiogram will be monitored. Afterward patients will receive fingolimod capsules at home, once daily orally at least for 12 months. Patients will be visited at 2 weeks, 1 month, 2month, 3 month, 9 month and 12 month after intervention. In each visit patients will be investigated for MS relapse, drug complication and safety and heart rate and blood pressure will be recorded. In order to investigate disease progression, expanded disability scale score (EDSS) will be recorded every 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201406018323N10
Registration date: 2015-01-03, 1393/10/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah university of medicine
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the efficacy and safety of oral fingolimod in relapsing remitting multiple sclerosis
Public title
The evaluation of the efficacy and safety of oral fingolimod in relapsing remitting multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.Patients with Relapsing- Remitting Multiple Sclerosis (RRMS) based on McDonald's Criteria (2010) 2.age between 18 to 45 years 3. EDSS between 0 to 5.5 4. at least one relapse in previous year while receiving first line disease modifying therapy 5.at least 2 relapses in previous 2 years while receiving first line disease modifying therapy 6. no relapses in 30 days previous to fingolimod initiation 7. negative pregnancy tests in child bearing women 8. positive history of varicella zoster virus vaccination or positive anti varicella zoster antibody in serum Exclusion criteria: 1. primary or secondary progressive MS 2. history of chronic systemic disease other than MS (lung, liver, kidney,...disease) 3. history of or active malignancy 4. presence of macular edema at baseline 5. acute or chronic active bacterial, viral or fungal infection 6. treatment with IV corticosteroids during 30 days previous to fingolimod initiation 7. history of treatment with cyclophosphamide or mitoxantrone at any time 8. history of treatment with immunoglobulins or monclonal antibodys in previous 6 months 9. history of treatment with methotroxate or azathioprine in previous 6 months 10. pregnancy or lactation 11. inocculation of live attenuated vaccines in previous 2 months 12. history of unstable angina, MI, TIA or CVA in previous 6 months 13. history of hospitalization due to decompensated heart failure in previous 6 months 14. Canada heart association class 3 or 4 heart failure 15. history or presence of second degree mobitz type AV block, third degree AV block or sick sinus syndrome, except having functional cardiac pace maker 16. QT interval more than 500 millisecond on baseline EKG 17. treatment with antiarythmic drugs class 1a or class 3 18. AST or ALT two folds normal upper limit 19. ALP 1.5 folds normal upper limit 20. direct or total Billi more than normal upper limit 21. creatinin more than 1.7 mg/dl 22. WBC less than 3500/ mm3 23. lymphocyte count less than 800/ mm3 24. presence of uveitis
Age
From 18 years old to 45 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti boulvered, Kermanshah
City
Kermanshah
Postal code
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
35220

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
expanded disability score scale,EDSS
Timepoint
before intervention and every 3 months after intervention
Method of measurement
EDSS qustionair

Secondary outcomes

1

Description
annual relapse rate
Timepoint
before intervention and monthly after intervention
Method of measurement
physical examination by neurologist and EDSS questionair

2

Description
disability progression
Timepoint
before intervention and monthly after intervention
Method of measurement
one point increment in EDSS that remains for 3 months, without new relapse at the time of evaluation

3

Description
drug side effects
Timepoint
before intervention and monthly after intervention
Method of measurement
patient reported complications and designed drug side effect questionair

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
Emam Reza Hospital of Kermanshah
Full name of responsible person
Dr. Nazanin Razazian
Street address
Emam Reza Hospital, Parastar bulvard, Sorkhelijeh, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Mr. Shirzadian
Street address
Kermanshah University of Medical Sciences, building no.2, Shahid Beheshti boulvered, Kermanshah
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nazanin Razazian
Position
neurologist/ Associate Professor
Other areas of specialty/work
Street address
Neurology department, Emam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3427 6326
Fax
Email
nrazazian@kuma.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nazanin Razaziam
Position
neurologist/ Associate Professor
Other areas of specialty/work
Street address
Neurology department, Emam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3427 6326
Fax
Email
nrazaziazn@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elham Ouspid
Position
MD, resident of Neurology
Other areas of specialty/work
Street address
Neurology department, Emam Reza hospital, Neurology department, Emam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3427 6326
Fax
Email
elyouspid@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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