A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase

ovartis Pharma GmbH0 个研究点开始时间: 2011年9月30日最近更新: 2012年7月24日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

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 5).
•4. Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including) (see Appendix 7).
•5. Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
•6. Fatigue score assessed by mFIS of equal or greater than 14 at screening
•7. Willingness to participate in a structured interventional training program according to the study protocol
•8. Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
•9. Sufficient ability to read, to write, to understand, to communicate also electronically, and to have access to world wide web.
•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 226
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Patients who have been treated with:
•systemic corticosteroids or immunoglobulins within 1 month prior to randomization;
•immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization;
•monoclonal antibodies (including natalizumab) within 3 months prior to randomization;
•mitoxantrone within 6 months prior to randomization
•cladribine at any time.
•2. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
•3. Patients with any of the following cardiovascular conditions :
•history of cardiac arrest;
•history of myocardial infarction or with current unstable ischemic heart disease;
•history of angina pectoris due to coronary spasm or history of Raynaud syndrome
•Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the
•investigator;
•history or presence of a second-degree AV block, Type II or a third-degree AV
•Blockor an increased QTc interval >450 ms in males and in females corrected using
•Bazett’s formula.
•patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
•III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
•dofelitide);
•patients receiving beta-blockers
•proven history of sick sinus syndrome or sino-atrial heart block;History of symptomatic bradycardia or recurrent syncope, cerebrovascular disease, hypokalaemia, congestive heart failure or severe sleep apnea
•uncontrolled hypertension
•resting heart reate ?? 45 bpm
•4. Patients with severe respiratory disease, pulmonary fibrosis, or chronic obstructive
•pulmonary disease (Class III-IV).
•5. Patients with any of the following neurologic/psychiatric disorders:
•current substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures;
•progressive neurological disorder, other than MS, which may affect participation in the study.
•6. Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
•7. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator`s discretion
•8. Patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives of randomization, whichever is longer.
•9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory

研究者

发起方

ovartis Pharma GmbH

相似试验

进行中（未招募）

1 期

The safety of local application of dexamethasone (a corticosteroid) in the ear of people with Meniere's diseaseMeniere's diseaseMedDRA version: 17.0Level: PTClassification code 10027183Term: Meniere's diseaseSystem Organ Class: 10013993 - Ear and labyrinth disorders

EUCTR2014-001337-86-GBOtonomy Inc.

进行中（未招募）

不适用

A 6 month, multi-center, randomized, double-blind, placebo-controlled parallel design human study for the evaluation of the efficacy and safety of HT042 on height promoting in low-height childreEndocrine, nutritional and metabolic disease

KCT0000736Korea Yakult Corporation140

进行中（未招募）

1 期

A study to learn how well finerenone works; how safe it is; how it moves into, through, and out of the body; and the effects it has on the body when taken by children with chronic kidney disease and proteinuria in addition to angiotensin-converting enzyme inhibitor or angiotensin receptor blockerChronic kidney diseaseProteinuriaMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1Level: PTClassification code 10037032Term: ProteinuriaSystem Organ Class: 10038359 - Renal and urinary disorders

EUCTR2021-002071-19-NLBayer AG219

进行中（未招募）

1 期

EUCTR2021-002071-19-GRBayer AG219

进行中（未招募）

1 期

EUCTR2021-002071-19-SEBayer AG219