An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1250

Inclusion Criteria

1. Patients should complete the 24 month core study
2. Written informed consent provided prior to participation in extension study
3. Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

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

1. Premature discontinuation of the study drug during the core study FTY720D2301 due to:
a. An adverse event or serious adverse event or laboratory abnormality, except pregnancy
b. Conditions leading to permanent study drug discontinuation such as macular edema, elevated liver enzymes five times ULN (upper limit of normal), pulmonary function tests below 60% of baseline values. The full description of these exclusion criteria and monitoring guidelines is outlined in Appendix 4: Guidance on Safety Monitoring
2. Chronic disease of the immune system other than MS which may require immunosuppressive treatment
3. History or presence of malignancy
4. Known diagnosis of diabetes mellitus or a blood glucose obtained suspicious for diabetes (= 126 mg/dl or = 7 mmol/L if fasting; = 200 mg/dl or = 11.1 mmol/L if random)
5. Macular edema during the core study
6. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests
7. Previous treatment with cladribine, cyclophosphamide or mitoxantrone
8. Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months
9. Any medically unstable condition, that may interfere with the patient’s ability to cooperate and comply with the study procedures, as assessed by the treating physician
10. Any of the following cardiovascular conditions:
a. myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
b. cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
c. arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
d. history or presence of a third degree AV block
e. proven history of sick sinus syndrome or sino-atrial heart block
f. known history of angina pectoris due to coronary spasm or Raynaud’s phenomenon
11. Any of the following pulmonary conditions:
a. Severe respiratory disease or pulmonary fibrosis diagnosed [during the core study]
b. History of tuberculosis
c. Abnormal chest x-ray or high resolution computer tomography (HRCT) [at selected sites] suggestive of active pulmonary disease in the core study
12. Known history of alcohol abuse, chronic liver disease
13. Current participation in any clinical research study evaluating another investigational drug or therapy
14. Female patients that are nursing (lactating)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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