EUCTR2012-005394-31-GB进行中（未招募）1 期
MS-SMART: A Multi-Arm Phase IIb Randomised, Double Blind Placebo-Controlled Clinical Trial Comparing The Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis - MS-SMART: Multiple Sclerosis Secondary Progressive Multi-Arm Randomisation Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- C
- 入组人数
- 440
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
入选标准
- •Confirmed diagnosis of SPMS. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least one point in EDSS or clinical documentation of increasing disability in patients notes
- •EDSS 4.0-6.5
- •Aged 25 to 65 inclusive
- •Women and men with partners of childbearing potentialage must be using an appropriate method of contraception to avoid any unlikely teratogenic effects of the 3 drugs from time of consent, to 6 weeks after treatment inclusive
- •Women must have a negative pregnancy test within 7 days prior to the baseline visit) unless not of child bearing potential (e.g. have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy or they are postmenopausal)
- •Willing and able to comply with the trial protocol (e.g. can tolerate MRI and fulfils the requirements for MRI, e.g. not fitted with pacemakers or permanent hearing aids) ability to understand and complete questionnaires
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 440
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Pregnancy or breast feeding females
- •Baseline MRI scan not of adequate quality for analysis (e.g. too much movement artefact)
- •Significant organ co-morbidity (e.g. malignancy or renal or hepatic failure)
- •Relapse within 3 months of baseline visit
- ••Patients who have been treated with iv or oral steroids for an MS relapse/progression within 3 months of baseline visit (these patients can undergo future screening visits once the 3 month window has expired), patients on steroids for another medical condition may enter as long as the steroid prescription is not for multiple sclerosis (relapse or progression)
- •Use of Simvastatin at 80mg dose within 3 months of baseline visit (lower doses of Simvastatin and other statins are permissible)
- •Commencement of fampridine within 6 months of baseline visit
- •Use of immunosupressants (e.g. azathioprine, methotrexate, cyclosporine) or first generation disease modifying treatments (ß-interferons, glatiramer) within 6 months of baseline visit
- •Use of fingolimod/fumarate/teriflunomide/laquinomod/or other experimental disease modifying treatment (including research in an investigational medicinal product) within 12 months of baseline visit
- •Use of mitoxantrone/natalizumab/alemtuzumab/daclizumab if treated within 12 months of baseline visit
- •Primary progressive MS
- •Relapsing-remitting MS
- •Known hypersensitivity to the active substances and their excipients to any of the active drugs for this trial
- •Use of an SSRI- within 6 months of the baseline visit
- •Current use of tamoxifen
- •Current use of herbal treatments containing St. John’s Wort
- •Patients with a history of bleeding disorders or currently on anticoagulants
- •Use of monoamine oxidase inhibitors, phenytoin, L-tryptophan) and/or neuroleptic drugs within 6 months of the baseline visit
- •Use of: lithium, chlorpropamide, triamterene, spironolactone, within 6 months of the baseline visit
- •Current use of potassium supplements
- •Significant signs of depression
- •Bipolar disorder
- •A Beck Depression Index score of 19 or higher
- •Epilepsy/seizures
- •Receiving or previously received Electroconvulsive therapy ECT treatment
- •Routine screening blood values (LFT) >/ 3 x upper limit of normal (ULN) of site reference ranges (AST/ALT, bilirubin, ?GT)
- •Potassium <2.8mmol/l or >5.5mmol/l
- •Sodium <125mmol/l
- •Creatinine >130µmol/l
- •WBCs <3x109/l
- •Lymphocytes <0.8 x 109/l
- •Neutrophil count <1.0 x109 /l
- •Platelet count <90 x109 /l
- •Haemoglobin <8.0g/l
研究者
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