A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND
- Conditions
- primary progressive multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10063401Term: Primary progressive multiple sclerosis
- Registration Number
- EUCTR2007-002627-32-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
Patients who meet all of the following inclusion criteria during the Pre-Randomization Phase will be eligible for enrollment in the study: General male or female 25 through 65 years of age inclusive females of childbearing potential must have a negative pregnancy test at Baseline and use simultaneously two forms of effective contraception during the treatment and 3 months after discontinuation of study medication sign written informed consent prior to participating in the study Primary Progressive Multiple Sclerosis diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria): - one year of disease progression plus - two of the following: a) positive brain MRI (nine T2 lesions or four or more T2 lesions with positive visual evoked potential), b) positive spinal cord MRI (two focal T2 lesions), c) positive CSF. Central review of the evidence will be required prior to randomization. Patients who meet all three criteria do not need to be submitted for central review. duration of disease at Baseline - time since first reported symptoms between 2 and 10 years documented evidence of clinical disability progression in the 2 years prior to Screening - clinical disability progression should have been observed in each of the previous 2 years prior to Screening as per clinical judgment of the investigator. - in addition, disability progression must be documented by an increase in the EDSS score of at least 0.5 points at any time point during the 2 years prior to Screening. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted for central review. 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
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
Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study: history of MS attack/relapse as per clinical judgement of the investigator progressive disabling neurological disorder, other than PPMS pure cerebellar progressive syndrome or pure visual progressive syndrome or a pure cognitive progressive syndrome. presence of cervical spinal cord compression on Screening MRI relevant history of vitamin B12 deficit history of chronic active disease of the immune system other than MS which may require systemic immunosuppressive treatment or a known immunodeficiency syndrome history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin) known or ?new? diagnosis of diabetes mellitus (if Screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting and ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus) 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) active systemic bacterial, viral or fungal infections, or diagnosis of syphilis, borreliosis, HIV, Hepatitis B, Hepatitis C infection or any other active systemic bacterial, viral or fungal infections have received total lymphoid irradiation or bone marrow transplantation have been treated with: - systemic corticosteroids or adrenocorticotropic hormones (ACTH) within 3 months 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 within 6 months prior to randomization - any mitoxantrone less than 5 years prior to randomization or evidence of cardiotoxicity following mitoxantrone or mitoxantrone at a total cumulative life-time dose of more than 60 mg/m2 - cladribine, cyclophosphamide at any time any medically unstable condition, as assessed by the primary treating physician 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 PLS SEE PROTOCOL
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