EUCTR2007-002627-32-BE进行中（未招募）不适用
A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 970
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General inclusion criteria:
- •1. male or female
- •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 (refer to Section 7.5.9 for details)
- •4. sign written informed consent prior to participating in the study
- •Primary Progressive Multiple sclerosis / specific inclusion criteria :
- •1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria, Appendix 8):
- •one year of disease progression plus
- •two of the following:
- •- positive brain MRI (nine T2 lesions or four or more T2 lesions with positive visual evoked potential)
- •- positive spinal cord MRI (2 focal T2 lesions),
- •- positive CSF
- •Central review of the diagnostic criteria for PPMS will be required for all patients prior to randomization (refer to Appendix 9 for details).
- •2. duration of disease at Baseline
- •time since first reported symptoms between 2 and 10 years
- •3. 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.
- •4. disability status at Screening (V1 or V2)
- •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 970
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. history of MS attack/relapse as per clinical judgement of the investigator
- •2. progressive disabling neurological disorder, other than PPMS
- •3. pure cerebellar progressive syndrome or pure visual progressive syndrome or a pure cognitive progressive syndrome
- •4. presence of cervical spinal cord compression on Screening MRI
- •5. relevant history of vitamin B12 deficit
- •6. history of chronic active disease of the immune system other than MS which may require systemic immunosuppressive treatment or a known immunodeficiency syndrome
- •7. history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
- •8. 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)
- •9. 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)
- •10. evidence of syphilis, borreliosis, HIV, Hepatitis B, Hepatitis C infection or any other active systemic bacterial, viral or fungal infections
- •11. have received total lymphoid irradiation or bone marrow transplantation
- •12. have been treated with:
- •systemic corticosteroids or adrenocorticotropic hormones (ACTH) within 3 months prior to randomization
- •interferon-beta (IFN-*) 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 during previous 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
- •13. any medically unstable condition, as assessed by the primary treating physician
- •14. any of the following cardiovascular conditions (see enclosed protocol section 5.2)
- •15. any of the following pulmonary conditions (see enclosed protocol section 5.2)
- •16. any of the following hepatic conditions (see enclosed protocol section 5.2)
- •17. any of the following abnormal laboratory values (see enclosed protocol section 5.2)
- •18. 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
- •19. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
- •20. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization
- •21. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •22. negative for varicella-zoster virus IgG antibodies at Screening
- •23. have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to randomization
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