Department of Neurology

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A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis

Study duration
The core study will be considered completed for an individual patient, when he/she completes the Double-blind Treatment Phase. The study as a whole will be considered completed when all randomized patients remaining in the core study have completed the Double-blind Treatment Phase.

Patients who complete the 24-month Double-blind Treatment Phase may be eligible for participation in an extension phase which will be provided as a separate protocol. Patients who do not enter the Extension Phase should return for the Follow-up visit 3 months after the last dose of study drug. The investigator also must provide follow-up medical care for all patients who are prematurely discontinued from the study, or must refer them back to their referring physician for appropriate care.

Enrollment is scheduled to begin the end of June, 2006 and continue until all subjects are enrolled at all sites and continue for 2 yrs beyond that last subject.

Key Inclusion Criteria

  1. Females of childbearing potential must:
    • have negative pregnancy tests prior to entry into the Double-Blind Treatment Phase
    • agree to use adequate contraception during the treatment and 3 months after discontinuation of the study medication females who are either post-menopausal for 12 months prior to Randomization or surgically sterile (if documented), may be included without above requirements
  2. 18 through 55 years of age inclusive
  3. Sign written informed consent prior to participating in the study Multiple sclerosis
  4. Diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
  5. A relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization
  6. An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive
  7. Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization
  8. Patients who explicitly decline initiation or continuation of treatment with available disease modifying drugs for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.

Key Exclusion Criteria

  1. A manifestation of MS other than RRMS
  2. A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
  3. A history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
  4. A known or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting; ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
  5. A diagnosis of macular edema during Pre-randomization 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. Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
  7. Have received total lymphoid irradiation or bone marrow transplantation
  8. Have been treated with:
    • corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to randomization
    • IFN-β or glatiramer acetate within 3 months prior to randomization
    • immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to randomization
    • immunoglobulins and/or monoclonal antibodies (including natalizumab) within 6 months prior to randomization
    • cladribine, cyclophosphamide or mitoxantrone at any time
  9. Any medically unstable condition, as assessed by the primary treating physician
  10. Any of the following cardiovascular conditions:
    • myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease
    • history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon
    • cardiac failure at time of Screening (Class III, according to NYHA Classification; or any severe cardiac disease as determined by the investigator
    • history of cardiac arrest
    • history of symptomatic bradycardia
    • resting pulse rate <55 bpm prior to randomization
    • history of sick sinus syndrome or sino-atrial heart block
    • history or presence of a second degree AV block or a third degree AV block or an increased QTc interval >440 ms on Screening ECG
    • arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
    • history of a positive tilt test from workup for vasovagal syncope
    • hypertension, uncontrolled by medication
  11. Any of the following pulmonary conditions:
    • severe respiratory disease or pulmonary fibrosis
    • tuberculosis, except for history of successfully treated tuberculosis or history of prophylactic treatment after positive PPD skin reaction
    • abnormal chest High Resolution Computer Tomography (HRCT) suggestive of active pulmonary disease
    • abnormal Pulmonary Function Tests: FEV1;, FVC values lower than 70% of predicted value, DLCO values lower than 60% of predicted value
    • patients receiving chronic (daily) therapies for asthma
  12. Any of the following hepatic conditions:
    • known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome
    • total or conjugated bilirubin greater than the upper limit of the normal range
    • alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range
    • AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range
    • gamma-glutamyl-transferase (GGT) greater than 3 times the upper limit of the normal range
  13. Any of the following abnormal laboratory values:
    • serum creatinine greater than 1.7 mg/dL (150 µmol/L)
    • white blood cell (WBC) count <3,500/mm3 (<3.5 X 109 / L)
    • lymphocyte count <800/mm3 (<0.8 X 109 / L)
  14. Any of the following neurologic/psychiatric disorders:
    • history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures;
    • progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol.
  15. Unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
  16. Participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization
  17. History of fingolimod therapy.

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