EUCTR2017-003328-56-GB进行中（未招募）1 期
A phase 3 randomised, double blind, clinical trial investigating the effectiveness of repurposed simvastatin compared to placebo, in secondary progressive multiple sclerosis, in slowing the progression of disability - MS-STAT2
niversity College London Comprehensive Clinical Trials Unit0 个研究点目标入组 1,180 人开始时间: 2017年10月31日最近更新:
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
- 入组人数
- 1,180
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. Patients with a confirmed diagnosis of multiple sclerosis (MS) that have entered the secondary progressive stage at randomisation. 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 on the Expanded Disability Status Scale (EDSS), or clinical documentation of increasing disability
- •2. EDSS 4.0 - 6.5 (inclusive)
- •3. Aged 25 to 65 years old
- •4. Male or Female
- •5. Patients must be able and willing to comply with the terms of this protocol.
- •6. Written informed consent provided
- •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 1180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Relapse within 3 months of baseline visit
- •2. Patients that have been treated with steroids (intravenous and/or oral) due to
- •MS relapse/progression within 3 months of baseline visit. These patients may
- •undergo a further screening visit once the 3 month window has expired and may be
- •included if no steroid treatment has been administered in the intervening period
- •(Note: Patients on steroids for another medical condition may be included in the
- •trial provided the steroid prescription is not for MS relapse/progression)
- •3. Significant organ co-morbidity e.g. cardiac failure, renal failure, malignancy
- •4. Screening levels of alanine aminotransferase (ALT) / aspartate aminotransferase
- •(AST) or creatinine kinase (CK) = 3x upper limit of normal (ULN)
- •5. Current use of a statin; or any use within the last 6 months
- •6. Medications that interact unfavourably with simvastatin as outlined in the
- •current summary of product characteristics (SmPC); including but not limited to
- •CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole,
- •fluconazole, HIV protease inhibitors (e.g. nelfinavir), boceprevir ,
- •erythromycin, clarithromycin, telithromycin, telaprevir, nefazodone, fibrates
- •(including fenofibrates), nicotinic acid ( or products containing niacin), azole
- •anti-fungal preparations, macrolide antibiotics, protease inhibitors, verapamil,
- •amiodarone, amlodipine, gemfibrozil, ciclosporin, danazol , diltiazem,
- •rifampicin , fusidic acid, grapefruit juice or alcohol abuse
- •7. Primary progressive MS
- •8. Diabetes Mellitus Type 1
- •9. Uncontrolled hypothyroidism
- •10.Female participants that are pregnant or breast feeding. Women of child bearing
- •potential (WOCBP) who are unwilling or unable to use an acceptable method to
- •avoid pregnancy for the entire study period, and up to 4 weeks after the last
- •dose of study drug.
- •11. Use of immunosuppressants (e.g. azathioprine, methotrexate, ciclosporine) or
- •disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the
- •previous 6 months.
- •12. Use of mitoxantrone, natalizumab, alemtuzumab, daclizumab or other monoclonal antibody treatment, if treated within the last 12 months.
- •13. Use of fingolimod, fumarate, teriflunomide within the last 12 months.
- •14. Use of other experimental disease modifying treatment within the last 6 months
- •15. Commencement of Fampridine = 6 month from day of randomisation
- •16. Concurrent participation in another clinical trial of an investigational
- •medicinal product or medical device
研究者
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