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.

• Conditions: Relapsing multiple sclerosis.; MedDRA version: 12.1Level: LLTClassification code 10048393Term: Multiple sclerosis relapse

• Registration Number: EUCTR2010-019029-32-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-07
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1350

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 such as 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 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