NCT00869726已完成2 期
A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 10
- 主要终点
- Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
研究概览
简要总结
The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis.
Dirucotide is generic name for MBP8298.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of SPMS
- •Absence of relapse in the 3mos prior to baseline
- •EDSS of 3.5 - 6.5
- •Pyramidal or Cerebellar FSS greater than or equal to 3
- •A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive.
- •Informed consent
- •Subject reliability and compliance
排除标准
- •Diagnosis of Primary Progressive MS
- •Subjects have previously received MBP8298
- •Recent history of malignancy, with the exclusion on basal cell carcinoma.
- •Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment
- •Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.
- •Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period.
- •History of anaphylactic/anaphlactoid reactions to glatiramer acetate
- •Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant
- •Known allergy to Gadolinium-DTPA
- •Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment
- •Treatment at any time wtih an altered peptide ligand
- •Any conditions that could interfere with the performance of study specific procedures e.g.MRI
- •Previous randomization to this study
- •Known positivity for HIV, Hepatitis B, or Hepatitis C
- •Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos.
- •Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly
- •Known or suspected current or past alcohol or drug abuse (within the last year)
- •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
- •Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study
研究组 & 干预措施
Dirucotide
Experimental
干预措施: dirucotide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
时间窗: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
次要结局
- Brain Atrophy by MRI(baseline, 12mos, 24mos)
- degree of change in EDSS(baseline, 24mos)
- Activity analysis of T2 and Gadolinium enhancing lesions(12mos and 24mos)
- Relapse rates(baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos)
- Quality of life as measured by Short Form 36 (SF-36) or MSQoL54(baseline, 6mos, 12mos, 18mos, 24mos)
- Lesion burden(12mos and 24mos)
- Degree of change in MS Functional Composite Index (MSFC)(baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos)
研究者
研究点 (10)
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