ISRCTN98373474已完成不适用
A double-blind placebo-controlled multicenter study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS)
BioMS Technology Corp (Canada)0 个研究点目标入组 553 人开始时间: 2005年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 553
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects, 18-65 years of age
- •2. Documented history of SPMS. SPMS is defined as an MS patient who has been diagnosed with MS for at least 3 years, and in the 3-year period prior to enrolment must have documented progression of their pyramidal or cerebellar Kurtzke functional subscores (FSS) in the absence of acute relapses. (In the absence of documented FSS changes, clinical notes documenting changes consistent with these changes will be acceptable). The subject must also have experienced at least one acute relapse as part of their diagnosis of Relapsing/Remitting Multiple Sclerosis (RRMS). Only one relapse prior to diagnosis of MS can be in accordance with the McDonald diagnostic criteria as long as cranial magnetic resonance imaging (MRI) findings consistent with the diagnosis of MS are also present.
- •3. Absence of relapse in the 3 months prior to baseline
- •4. EDSS of 3.5 ? 6.5
- •5. Pyramidal or Cerebellar FSS =3
- •6. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
- •7. In the Investigator?s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
排除标准
- •1. Diagnosis of Primary Progressive MS
- •2. Subjects have previously received MBP8298
- •3. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma
- •4. Steroid therapy within 30 days prior to first dose, or any other treatment known to be used for putative or experimental MS treatment
- •5. Therapy with ß-interferon, glatiramer acetate, mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g., intravenous immunoglobulin [IVIG]) or immunosuppressive drugs, including recombinant or non-recombinant cytokines or plasma exchange, within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or adrenocorticotropic hormone (ACTH) for relapse treatment.
- •6. Initiation of therapy with 4-aminopyridine (4-AP) or 3,4-diaminopyridine (3,4-DAP)
- •7. History of anaphylactic/anaphylactoid reactions to glatiramer acetate
- •8. Abnormal laboratory values at the Baseline Visit deemed by the Investigator to be clinically significant
- •9. Known allergy to Gadolinium-DTPA
- •10. Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment e.g. anti-CD4, anti-CD52, anti-VLA4, anti-CD20
- •11. Treatment at any time with an altered peptide ligand
- •12. Any conditions that could interfere with the performance of study-specific procedures (e.g., MRI)
- •13. Previous randomization to this study
- •14. Known positivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- •15. Participation in any other non-MS clinical trial within 30 days prior to performance of the first study-specific test (the screening/baseline visit), or any investigational therapy in the past 6 months
- •16. Females who are breastfeeding, pregnant (pregnancy test at screening), or not using a medically approved method of contraception regularly
- •17. Known or suspected current or past alcohol or drug abuse (within the last year)
- •18. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements
- •19. Any other condition that, in the Investigator?s opinion, makes the subject unsuitable for participation in the study
研究者
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