NCT00869986已完成2 期
A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting 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
- 218
- 试验地点
- 6
- 主要终点
- Annualized relapse rate
研究概览
简要总结
The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18-50 years of age
- •Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)
- •At least 2 years history of MS before trial entry
- •Documented history of 2 or more exacerbations in the 2 years prior to trial entry
- •Stable neurological status for at least 30 days before first study drug administration
- •Have an EDSS from 0-5.5
- •If female, she must either
- •be post-menopausal or surgically sterilized; or
- •use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
- •be neither pregnant nor breast-feeding
- •Willingness and ability to comply with the protocol for the duration of the study
- •In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
- •Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
排除标准
- •Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)
- •Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma
- •Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC),
- •Clinically significant ECG abnormalities at screening
- •Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
- •Have current autoimmune disease, compromised immune function or infection
- •History of allergic reactions to glatiramer acetate
- •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 ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test
- •Therapy with mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. 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 ACTH for relapse treatment
- •Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20,
- •Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium- DTPA
- •Participation in any other trial of an investigational agent within 90 days prior to screening
- •History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening
- •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
Annualized relapse rate
时间窗: 15 months
次要结局
- Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)(baseline, 15, 24 and 27 months)
- Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)(baseline, 15, 24 and 27 months)
- Proportion of patients relapse-free(15, 24, and 27 months)
- Activity analysis of T2 and Gadolinium enhancing lesions(15 and 27 months)
研究者
研究点 (6)
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