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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1850

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 defined by 2005 revised McDonald criteria
4. Patients with Expanded Disability Status Scale (EDSS) SCORE OF 0-6.5.
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 such as known immunodeficiency syndrome.
3. History or presence of malignancy other than localized basal or squamous cell carcinoma of the skin.
4. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
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 2 months 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: N/A<br>;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.<br><br>Please see Section 9.3 of the enclosed protocol for a detailed description.

Secondary Outcome Measures

Name	Time	Method

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