ISRCTN82598726已完成3 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 964
研究概览
简要总结
2024 Protocol article in https://doi.org/10.1136/bmjopen-2024-086414 (added 17/09/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 24/05/2020:
- •1. Patients with a confirmed diagnosis of multiple sclerosis (MS) that have entered the secondary progressive stage. 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 1 point if EDSS score <6, or an increase of 0.5 points if EDSS score =6, or clinical documentation of increasing disability
- •2. EDSS 4.0 - 6.5 (inclusive)
- •3. Aged 25 to 65 years old
- •4. Patients must be able and willing to comply with the terms of this protocol
- •5. Written informed consent provided
- •Previous participant inclusion criteria as of 19/10/2018:
- •1. Patients with a confirmed diagnosis of multiple sclerosis (MS) that have entered the secondary progressive stage. 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 1 point if on the Expanded Disability Status Scale (EDSS) score <6, or an increase of 0.5 point if EDSS score =6, or clinical documentation of increasing disability
- •2. EDSS 4.0 - 6.5 (inclusive)
- •3. Aged 25 to 65 years
- •4. Patients must be able and willing to comply with the terms of this protocol
- •5. Written informed consent provided
- •Previous participant inclusion criteria:
- •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
排除标准
- •Current participant exclusion criteria as of 15/11/2023:
- •Current participant exclusion criteria:
- •1. Relapse within 3 months of baseline visit. Patients will be eligible where 3 months from the final day of the relapse, has elapsed by the date of the baseline visit
- •2. Patients that have been treated with steroids (intravenous and/or oral) due to MS relapse/progression within 3 months from the final day of relapse to the 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 creatine kinase (CK) =3 x 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, clrithromycin, 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, elbasvir, grazoprevir, ticagrelor, daptomycin, grapefruit juice or alcohol abuse;
- •7. Primary progressive MS
- •8. Diabetes mellitus type 1
- •9. Uncontrolled hypothyroidism
- •10. Female participants who are pregnant or breastfeeding. Women of childbearing 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, dimethyl fumarate, teriflunomide, cladribine within the last 12 months
- •14. Use of other experimental disease-modifying treatment within the last 6 months
- •15. Commencement of fampridine =6 months from the day of randomisation
- •16. Concurrent participation in another clinical trial of an investigational medicinal product or medical device
- •17. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Previous participant exclusion criteria from 24/05/2020 to 15/11/2023:
- •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. Patients on steroids for another medical condition may be included in the trial provided.
- •the steroid prescription is not fo
研究者
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