A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS
- Conditions
- Primary progressive multiple sclerosis.MedDRA version: 17.0Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2007-002627-32-BE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 970
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
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
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