Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Study Overview
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Brief Summary
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This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.

Official Title
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A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Fingolimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with relapsing remitting Multiple Sclerosis Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5. Exclusion Criteria: Patients with MS other than relapsing remitting MS Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. Patients who have been treated with: systemic corticosteroids or immunoglobulins within 1 month prior to baseline; immunosuppressive medications within 3 months prior to baseline; monoclonal antibodies within 3 months prior to baseline; cladribine, mitoxantrone or alemtuzumab at any time. Uncontrolled diabetes mellitus at screening Diagnosis of macular edema during Screening Phase 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. Patients who have received total lymphoid irradiation or bone marrow transplantation. Patients with certain cardiovascular conditions and/or findings in the screening ECG Patients with certain liver conditions Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingolimod<br>Open-label fingolimod 0.5 mg, taken orally once daily for 4 months | Drug: Fingolimod<br>* Fingolimod will be supplied as 0.5mg capsules in bottles of 35.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. | The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing-Remitting