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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 2 October 2012
Main ID:  EUCTR2010-019029-32-AT
Date of registration: 08/06/2010
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.
Scientific title: A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.
Date of first enrolment: 28/07/2010
Target sample size: 2400
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019029-32
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Austria Czech Republic Denmark Finland Germany Greece Hungary Ireland
Italy Netherlands Portugal Slovakia Spain Sweden United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Male or female subjects aged 18-65 years
3. Subjects with relapsing forms of MS (RRMS, SPMS with superimposed relapses), defined by 2005 revised McDonald criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

1. Patients with a manifestation of MS other than relapsing MS.
2. Patients with a history of chronic disease of the immune system other than MS , which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
4. Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
5. Diagnosis of macular edema during Screening Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).
6. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
7. Negative for varicella-zoster virus IgG antibodies at Screening
8. Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to baseline
9. Patients who have received total lymphoid irradiation or bone marrow transplantation.
10. Patients who expect to be treated with any disease modifying drugs (DMD) during the study (IFN-ß, glatiramer acetate); however no washout is needed for DMDs prior to baseline.

For a detailed descrition of all exclusion criteria, please see section 4.2 of the enclosed protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Relapsing multiple sclerosis.
MedDRA version: 12.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
Intervention(s)

Product Name: FTY720
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod hydrochloride
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)
Main Objective: To evaluate the safety and tolerability profile of FTY720 0.5 mg in patients with relapsing forms of MS including a broader patient population than has been previously studied in clinical trials with FTY720.
Primary end point(s): Adverse events (AEs), laboratory, vital signs, 1st dose Holter-ECG-recording, and ophthalmology assessments and skin assessment data will be used to evaluate the primary objective.

Please see Section 8 of the enclosed protocol for a detailed description.
Secondary Objective: N/A
Secondary Outcome(s)
Secondary ID(s)
2010-019029-32-DE
CFTY720D2316
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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