EUCTR2011-001692-39-DE进行中（未招募）不适用
A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression
ovartis Pharma GmbH0 个研究点开始时间: 2011年6月8日最近更新:
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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. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
- •2. Male or female subjects aged 18-65 years.
- •3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4).
- •4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix 8).
- •5. Patients with high disease activity despite treatment with a disease modifying therapy (> 1 relapse in the previous year, > 9 hyperintense T2 lesions or > 1 Gd-enhancing lesion or non-responding” which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year)
- •or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).
- •or patients who are already treated with fingolimod within the EU label criteria for at
- •least 7 days with or without having participated and completed study
- •CFTY720DDE17
- •6. Diagnosis of depression according to ICD-10 criteria
- •7. Mild-moderate depression assessed by BDI-II score between 14-28 inclusively measured on V1 and on V2
- •8. Sufficient ability to read, write, communicate and understand
- •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 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with a history of chronic disease of the immune system other than MS which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. Patients with Crohns disease or ulcerative colitis are excluded without exception.
- •2. History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin).
- •3. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- •4. Negative for varicella-zoster virus IgG antibodies at Screening.
- •5. Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to start of fingolimod.
- •6. Patients who have received total lymphoid irradiation or bone marrow transplantation.
- •7. Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-ß, glatiramer acetate); however no washout is needed for DMDs prior to start of fingolimod.
- •8. Patients who are or have been treated with:
- •immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to start of fingolimod
- •Systemically applied corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to Screening visit (V1) (nevertheless, topical application is permitted);
- •Immunosuppressive medications such as azathioprine or methotrexate, within 3 months prior to start of fingolimod;
- •Cyclophosphamid and mitoxantrone within 6 months prior to start of fingolimod
- •cladribine at any time.
- •current psychological or pharmacological treatment for depression (MAO inhibitors in particular), a washout period of 14 days prior visit 2 is required
- •current treatment with linezolid, a washout period of 1 month prior start of fingolimod is required
- •9. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
- •10. Patients with any of the following cardiovascular conditions:
- •? Patients receiving antiarrythmics class Ia (e.g. quinidine, disopyramide) or
- •class III (e.g. amiodarone, sotalol) or beta blockers
- •? Patients receiving heart rate lowering calcium channel blockers (e.g.
- •verapamil, diltiazem or ivabradine) or other substances which may
- •decrease heart rate (e.g. digoxin, anticholinesteratic agents or pilocarpine).
- •? 2nd degree Mobitz Type II or higher degree AV block, Sick-sinus
- •syndrome, or Sino-atrial heart block
- •? Significant QT prolongation (QTc>470 msec (female) or >450 msec
- •? History of symptomatic bradycardia or recurrent syncope, known
- •ischaemic heart disease, cerebrovascular disease, history of myocardial
- •infarction, hypokalaemia, congestive heart failure, history of cardiac arrest,
- •uncontrolled hypertension, or severe sleep apnea
- •11. Patients with severe hepatic dysfunction (Child-Pugh-Class C)
- •12. Patients who are not currently treated with fingolimod with the following cell counts: white blood cell (WBC) count <3,500/mm3 or lymphocyte count <800/mm3. Patients who are currently treated with fingolomod with the following cell counts: white blood cell (WBC) count <3,500/mm3 or lymphocyte count <200/mm3
- •13. Patients with any of the following neurologic/psychiatric disorders:
- •history of substance abuse (drug or alcohol) in the past five years or any other factor (i.e. serious psychiatric condition) t
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