EUCTR2018-000620-34-SE进行中（未招募）1 期
Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS
Department of Clinical Neuroscience, Karolinska Institutet0 个研究点目标入组 200 人开始时间: 2018年3月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1.An acute exacerbation, relapse, in persons with RRMS, either newly diagnosis or on treatment with one of the long-term immunomodulatory drugs, or possible MS where the diagnosis is supported by typical MRI or cerebrospinal fluid changes typical of MS (this enables inclusion of persons with a first neuroinflammatory bout, with high risk of developing MS before fulfilling the McDonald criteria for definite MS, or high risk for developing MS in the category clinically isolated syndrome (CIS)/possible MS with supporting MRI lesions and/or cerebrospinal fluid abberations suggesting intra-thecal immunoglobulin synthesis with oligoclonal bands/and/or increased free Kappa Light chains. The relapse should be deemed to require relapse treatment by the investigator and affect a functional domain with a minimum of grade 2.
- •2.18-55 years of age
- •3.Affection of any of the following EDSS sub-domains representing the targeted neurological deficit: 1. Visual function. grade 0-6, 2. Brain stem function grade 0-5. 3. Pyramidal function, grade 0-6. 4. Cerebellar function, grade 0-5. 5. Sensory function grade 0-6, and deterioration at least one step in any of these EDSS domains
- •4.EDSS = 6 before the acute exacerbation
- •5.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly according to CTFG, September 2014 Recommendations related to contraception and pregnancy testing in clinical trials”. Such methods include:
- •a. Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
- •-intravaginal
- •-transdermal
- •b. progestogen-only hormonal contraception associated with inhibition of ovulation
- •- injectable
- •- implantable
- •c. intrauterine device (IUD)
- •d. intrauterine hormone-releasing system (IUS)
- •e. bilateral tubal occlusion
- •f. total abstinence or vasectomized partner.
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.A peudo-relapse should be excluded, as deemed by the experienced treating neurologist, and as evidenced by an active infection, likely with fever, with reappearing new signs and symptoms in a previously affected neurological function.
- •2.Inability to provide informed consent
- •3.Concomitant medication with drugs which may increase the plasma concentration of Imatinib - ketokonazol, itrakonazol, erythromycin and claritomycin
- •4.Concomitant medication with drugs which may decrease the plasma concentration of Imatinib: Dexametason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon, Hypericum perforatum (Johannesört, St John's wort).
- •5.Female patients with childbearing potential, if pregnancy cannot be excluded by pregnancy test (urine point-of-care pregnancy test).
- •6.Patient is participating in other interventional study
- •7.General infection or any other condition judged by the treating neurologist to contra-indicate Imatinib
- •8.Any laboratory deviation of general bodily functions such as kidney, or renal function judged to be of clinical significance by the treating neurologist constitutes an exclusion criteria.
- •9.Patients with a positive Hepatitis B-DNA test result or serology indicating latent infection.
研究者
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