NCT02686788已完成2 期
TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial
Dr. Frank Behrens5 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Comparison of average total number of contrast enhancing lesions
研究概览
简要总结
The purpose of this study is to assess the impact of TMP001 in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of contrast enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during treatment with TMP001 is compared to the average total number of CELs on brain MRI scans at week -4 and baseline in these patients .
Based on promising preclinical results, the investigators assume a comparable effect of TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory substances in recent clinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 55 years
- •Definite diagnosis of RRMS (according to revised McDonald criteria, Polman et al. 2011, Annals of Neurology 69:292-302)
- •At least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years
- •At least one contrast-enhancing lesion (CEL) on the screening MRI scan at week (-4)
- •EDSS of 0 - 5 (inclusive) at screening (week -4)
- •Women of childbearing potential (WOCBP) must use 2 adequate forms of contraception to avoid pregnancy throughout the trial (such as a double barrier method) and for up to 8 weeks after the last dose of TMP001 in such a manner that the risk of pregnancy is minimized
- •Written informed consent obtained prior to the initiation of any protocol-required procedures
- •Compliance to study procedure and study protocol
排除标准
- •History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
- •Clinically severe active infection (e.g., pneumonia, septicaemia) within the 1 month prior to Screening.
- •Diagnosis of neuromyelitis optica, clinically isolated syndrome, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis
- •History of drug or alcohol abuse within 2 years of inclusion to the study
- •Relapse or corticosteroid treatment within 30 days before screening (week -4)
- •Interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod therapy had to have been stopped 3 or more months before enrolment
- •Immunosuppressive medication such as azathioprine or methotrexate, Ciclosporin, cyclophosphamide, mycophenolate mofetil, mitoxantrone or cladribine at any time
- •Any previous therapy with alemtuzumab, ocrelizumab, ofatumumab, rituximab, belimumab, natalizumab, total body irradiation, or bone marrow transplantation
- •Any investigational drug or placebo within 12 weeks prior to enrolment OR > 5 half-lives prior to screening (week -4), whichever is longer
- •Women that are pregnant or currently breast feeding
- •Concurrent participation in other clinical trials
- •History of, or current diagnosis of, malignancy (including previously treated skin cancer other than successfully treated basal and squamous skin cancer with no evidence of recurrence within 5 years)
- •Inability to complete an MRI or contraindications for MRI, including but not limited to claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, or nerve stimulators
- •Hypersensitivity to contrast agent (Gadolinium, resp. gadopentetate-dimeglumine)
- •Any reason in the discretion of the investigator regarding the safe participation of the patient in the study or for any other reason, the investigator considers the patient inappropriate for participation in the study.
- •White blood count (WBC) <3000 mm3 at screening (week -4)Lymphocytes < 800 mm3 at screening (week -4)
- •Exclusion criteria regarding the study medication:
- •Patients with known hypersensitivity to study medication
- •Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- •Patients with a history of peptic ulcer disease and/or gastrointestinal bleeding
- •Chronic or acute renal, hepatic or metabolic disorder
- •Patients with a history of myocardial infarction, ischemic stroke or known heart failure
- •Patients with known thrombophilia or abnormal clinically significant coagulation parameter at screening (week -4)
研究组 & 干预措施
TMP001
Experimental
600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks
干预措施: TMP001 (Drug)
结局指标
主要结局
Comparison of average total number of contrast enhancing lesions
时间窗: at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24
Comparison of average total number of contrast enhancing lesions (CELs) on Brain MRI scans at weeks 4, 8, 12, 16, 20 and 24 as compared to the average total number of CELs on brain MRI scans at week -4 and baseline (BL)
次要结局
- Comparison of average total volume of contrast enhancing lesions(at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24)
- Comparison of T2- hyperintense lesions as assessed in MRI(at week 0 (baseline) and week 24)
- Comparison of T1-hypointense lesions as assessed in MRI(at week 0 (baseline) and week 24)
- relapse rate(week -4 until week 24)
- Assessment of Lipid profile at different time points(at week 0 (baseline), week 12 and 24)
- Pain questionnaire(at week 0 (baseline), week 12 and week 24)
- Expanded disability status scale (EDSS)(at week 0 (baseline), week 12 and 24)
- TMP001-concentrations(week 4, 8, 12, 16, 20 and 24)
研究者
Dr. Frank Behrens
head of clinical research
Fraunhofer Institute for Molecular Biology and Applied Ecology
研究点 (5)
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