EUCTR2005-001009-25-IT进行中（未招募）不适用
Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA
DR DIMENSIONE RICERCA0 个研究点开始时间: 2006年3月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 relapsing-remitting forms of Multiple Sclerosis (according to McDonald s criteria; 28) with disease duration > 3 months and - 5 years. 2. EDSS score between 1.0 and 5.5, inclusive. 3. Currently treated with, and tolerating, Interferon beta, and having received this treatment for more than 3 and less than 12 months. 4. Age between 18 and 50 years, inclusive. 5. Patients must agree to avoid macrolids, including erytromicine and claritromicine for the whole study duration. 6. A woman of child-bearing potential must agree to adapt the proper behaviour adequately to avoid pregnancy while on study. 7. Negative pregnancy test results at screening day (all women of childbearing potential only). 8. Consent to go on the diet (appendix 2). 9. Written informed consent. 10. Serum lipid profile, as defined in appendix 3. 11. Adequate bone marrow, renal, and hepatic function, as defined in appendix 4.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any disease other than Multiple Sclerosis that would better explain the patient s signs and symptoms. 2. Primary progressive MS. 3. Secondary progressive MS. 4. Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure. 5. Previous confirmed venous thromboembolic disease including deep vein phlebitis and/or pulmonary embolism or known hemostatic disorder predisposing to thromboembolic complications. 6. Uncontrolled Seizure disorder. 7. Myopathy or clinically significant liver disease. 8. Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study. 9. Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study. 10. Well-known hypersensitivity to either Atorvastatin or Interferon β or other human proteins including albumin.11. Well-known hypersensitivity to gadolinium. 12. Inability to undergo a MRI scan. 13. A relapse started within 30 days prior to screening or between screening and baseline. 14. A history of substance abuse (hard and soft drugs, alcoholic drinks) in the 90 days prior to screening. 15. Previous (at any time ) therapy with any of the following: monoclonal antibodies, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocoticotropic hormone; ACTH), total lymphoid irradiation. 16. Previous therapy, administrated for ≥12 months, with other interferon beta drugs, Mitoxantrone, Azathioprine or Glatiramer acetate in the 12 months before start of the currently interferon beta treatment.. 17. Previous treatment (at any time) with statins. 18. Treatment with any of the following in the 30 days before baseline: systemic corticosteroids, ACTH, or other investigational drugs.
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