500 Boylston Street, Boston, MA 02116 617-419-4700
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The purpose of this study is to evaluate whether FTY720 is effective in delaying MS
disability progression compared to placebo in patients with PPMS.
Active, not recruiting
Ages:25 - 65
Inclusion Criteria: General 1. sign written informed consent prior to participating in the study 2. 25 through 65 years of age inclusive 3. females of childbearing potential must: - have a negative pregnancy test at Baseline (prior to randomization) and - use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication Primary Progressive Multiple sclerosis. 1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria): 2. time since first reported symptoms between 2 and 10 years 3. evidence of clinical disability progression in the 2 years prior to Screening 4. disability status at Screening - EDSS score of 3.5-6.0 inclusive - pyramidal functional system score of 2 or more - 25'TWT less than 30 seconds Exclusion Criteria: PPMS specific: - History of relapses/attacks - Progressive neurological disorder other than PPMS - Pure cerebellar syndrome or pure visual progressive syndrome or pure - cognitive progressive syndrome - Presence of spinal cord compression at screening MRI - Relevant history of vitamin B12 deficit - Evidence of syphilis or borreliosis at Screening Cardiovascular conditions: - Myocardial infarction within the past 6 months or current unstable ischemic heart disease - History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon - Severe cardiac failure or cardiac arrest - History of symptomatic bradycardia - Resting pulse <55 bpm pre-dose - History of sick sinus syndrome or sino-atrial heart block - History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms) - Arrythmia requiring treatment with class III antiarrythmic drugs - History of positive tilt test from workout of vasovagal syncope - Hypertension, not controlled with medication Pulmonary: - Severe respiratory disease or pulmonary fibrosis - TB - Abnormal X-ray, suggestive of active pulmonary disease - Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO - Patients receiving chronic (daily) therapies for asthma Hepatic: - Known history of alcohol abuse, chronic liver or biliary disease - Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome - AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN Other: - History of chronic disease of the immune system other than MS - Malignancy (other than successfully treated SCC or BCC) - Diabetes Mellitus - Macular Edema present at screening - HIV, Hepatitis C or B, other active infection - History of total lymphoid irradiation or bone marrow transplantation - Serum creatinine >1.7 mg/dl - WBC <3500 cells/mm3 - Lymphocyte count <800 cells/mm3 - History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures - Unable to undergo MRI scans - Participation in any therapeutical clinical research study in the 6 months prior to randomization - Pregnant or lactating women - Drugs requiring wash-out period: 3 months: - Systemic corticosteroids or ACTH - INF-beta 6 months: - Immunosuppressive medication - Immunoglobulins - Monoclonal antibodies - Drugs that exclude participation in the study: - Cladribine - Cyclophosphamide - Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study) Other protocol-defined inclusion/exclusion criteria may apply.
Phase: Phase 3
Trial ID: NCT00731692
Not Accepting Healthy Volunteers