EUCTR2004-004519-43-SK进行中（未招募）1 期
Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Protocol section 4.1.1: MS-related Inclusion Criteria
- •1) Diagnosis of relapsing MS types 1-4 based on McDonald criteria” as revised in
- •2005 (Appendix 1), without taking into account the screening MRI results
- •2) EDSS score of = 6.5 (Appendix 2)
- •3) Between 12 months and 1 month previous: 1 or more MS attack (which has been
- •documented in prior medical records) or a brain MRI with a gadolinium-enhancing
- •lesion consistent with an MS lesion (based on radiology report or investigator review
- •Protocol section 4.1.3: Other Inclusion Criteria
- •1) Signed written informed consent
- •2) Men or women 18-59 years of age
- •3) If female: postmenopausal for the past year (confirmed by an FSH level greater
- •than 25 mIU/mL unless the patient is receiving HRT), or surgically sterile (i.e.
- •tubal ligation, hysterectomy) or of childbearing potential with a reliable form of
- •contraceptive protection:
- •i) Intrauterine device
- •ii) Systemic hormonal contraception by the female
- •iii) Spermicide with or without a male or female barrier method
- •iv) Abstinence
- •Protoocl section 4.2.1: Inclusion Criteria at Baseline:
- •1) Screen MRI meets the Paty criteria” of: = 4 T2 lesions or = 3 T2 lesions if at least 1 is periventricular. It is the responsibility of a site investigator to make this
- •determination.
- •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
排除标准
- •Protocol section 4.1.2: MS-related Exclusion Criteria
- •1) MS attack or systemic corticosteroids within 1 month
- •2) MS treatments which are given to primarily treat symptoms:
- •a) Within 3 months: if part of an IRB/EC approved trial
- •b) Otherwise may remain on the regimen if it is unchanged within 1 month and is
- •unlikely to change before week 16. This includes cannabis-related agents as well
- •as categories such as over-the-counter, herbal and nutritional supplement.
- •The following refer to any other agents given to treat MS (approved or unapproved):
- •3) Within 3 months: interferon beta, glatiramer acetate, or plasmapheresis
- •4) Within 12 months: natalizumab, intravenous immunoglobulin, cytapheresis,
- •azathiaprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone,
- •mycophenolate, pixantrone, sirolimus, tacrolimus or other agents typically used to
- •prevent transplant rejection or as cancer chemotherapy, excluding hormonal
- •5) Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation,
- •vaccine therapy for MS or monoclonal antibodies whose effects may be longer than 1
- •year such as alemtuzumab, daclizumab or rituxan (rituximab)
- •6) Within 3 months: any other agents given for non-symptomatic treatment of MS which
- •were not included above in items 3-5 such as HMGCoA-reductase inhibitors,
- •glitazone”-type antidiabetics, 4-aminopyridine or products related to 4-
- •aminopyridine, antibiotics, hormone treatment, as well as categories such as overthe-
- •counter, herbal and nutritional supplement. However, if the agent is being taken
- •primarily to treat another medical condition, then it is allowed as long as the dose is
- •unchanged within 3 months and is unlikely to change before week 16
- •Protocol section 4.1.4: Other Exclusion Criteria
- •1) Women who are pregnant or may breastfeed before week 16
- •2) Within 1 month: an infection requiring systemic anti-infective treatment or a
- •vaccination. Exceptions are treatment of an uncomplicated urinary tract infection or
- •upper respiratory tract infection.
- •3) Within 3 months: participation in any IRB/EC investigational drug trial or treatment
- •with anti-TNF or other potentially immune modulating agents not already
- •4) Within 6 months: alcohol abuse or drug abuse as assessed by the investigator
- •5) History of HIV infection or progressive multifocal leukoencephalopathy (PML)
- •6) History of hereditary or acquired immunodeficiency, except for that caused by
- •pharmaceutical intervention; or currently present hereditary or acquired
- •immunodeficiency, including that caused by pharmaceutical intervention
- •7) A medical or neurological condition a) that may significantly interfere with the
- •absorption of an oral medication, b) which is likely to require a new medication or
- •hospitalization over the next 6 months or c) that may interfere with the assessment
- •8) Presence of pacemakers or foreign metal objects in the eyes, skin, or body which
- •would contraindicate an MRI scan
- •Protocol section 4.2.2: Exclusion Criteria at Baseline
- •1) Since screening, except for the use of systemic corticosteroids for an MS attack (see section 5), use of any new treatment which has been approved for or is being
- •evaluated for an effect on MS
- •2) Since screening, development or worsening of a medical or neurological condition
- •which a) may significantly interfere with the absorption of an oral medication, b) is
- •likely to require a new medication or hospitalization over the next 6 months, or c)
- •may interfere with the a
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