EUCTR2012-002968-27-GB进行中（未招募）不适用
A 48-week, double-blind, randomized, multi-center, parallelgroup study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute demyelinating optic neuritis - Study of efficacy and safety of fingolimod in acute demyelinating optic neuritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
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
- •Written informed consent must be obtained before any assessment is performed.
- •Male and female patients aged between 18 and 50 years, inclusive.
- •Clinical signs and symptoms of unilateral ADON (loss of vision, pain on movement, impairment of color vision) starting within the 14 days prior to intended randomization.
- •The qualifying ADON must be the first clinical episode of a probable demyelinating disease.
- •Able to undergo treatment with intravenous methylprednisolone (IVMP).
- •Received first IVMP dose prior to Visit 2.
- •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 126
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of any unexplained eye or neurological symptomatology lasting longer than 48 hours and indicative of a demyelinating disorder.
- •Bilateral optic neuritis.
- •Functionally or clinically relevant comorbidity of either eye such as glaucoma, optic nerve hypoplasia, macular full or partial thickness macular hole, macular edema, vitreomacular traction, epiretinal membrane, uveitis, or other diseases of the optic nerve or a history thereof.
- •High clinical likelihood of a form of optic neuritis other than ADON (e.g., severe optic disk edema, atrophic optic disk, retinal exudates, or hemorrhages).
- •Total average RNFL thickness of less than or equal to 80 µm in the fellow eye (unaffected eye)
- •Patients meeting any of the following cardiovascular conditions at Screening:
- •a. history of cardiac arrest;
- •b. severe untreated sleep apnea;
- •c. history of myocardial infarction; congestive heart failure;
- •d. ischemic heart disease;
- •e. cerebrovascular disease;
- •f. patients receiving current treatment with Class Ia or III
- •antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline, procainamide).
- •g. patients with relevant risk factors for QT prolongation, for
- •example, hypokalaemia, hypomagnesemia or congenital QT prolongation;
- •h. history or presence of a second-degree AV block Type II or
- •third-degree AV block or corrected QTc inverval >450 msec in males and >470 msec in females corrected using Fridericia’s formula (based on screening ECG report from central reader);
- •i. history of sick sinus syndrome or sino-atrial heart block;
- •j. uncontrolled hypertension despite prescribed medications;
- •k. resting heart rate <45 bpm;
- •Patients receiving current treatment (at randomization) beta blockers, heart-rate slowing calcium channel blockers (e.g. ivadrabine, verapamil, or diltiazem), or other substances which may decrease heart rate such as digoxin, anticholinesteratic agents or pilocarpine.
- •Advice from a cardiologist should be sought regarding the switch to non-heart-rate lowering medicinal products (for more details, please refer to Appendix 3)
- •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 test.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the study and for 2 months after stopping treatment. ” Highly effective contraception ” is defined as contraception that results in less than 1% unwanted pregnancies when used properly according to the label.
研究者
相似试验
进行中（未招募）
不适用
A study to evaluate the effects of fingolimod teatment in patients with acute demyelinating optic neuritisacute demyelinating optic neuritisMedDRA version: 15.1Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-002968-27-ITovartis Farma126
进行中（未招募）
不适用
A study to evaluate the effects of fingolimod teatment in patients with acute demyelinating optic neuritisacute demyelinating optic neuritisMedDRA version: 14.1Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-002968-27-ESovartis Farmaceutica, S.A126
进行中（未招募）
不适用
A study to evaluate the effects of fingolimod teatment in patients with acute demyelinating optic neuritisacute demyelinating optic neuritisMedDRA version: 16.0Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-002968-27-DEovartis Pharma Services AG126
进行中（未招募）
1 期
Study to evaluate the effect of LCZ696 compared to individualized medical therapy for comorbidities in Heart Failure with preserved Ejection Fraction (HFpEF) patientsHeart Failure with preserved Ejection Fraction (HFpEF)MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849EUCTR2016-003410-28-LVovartis Pharma AG2,500
进行中（未招募）
1 期
Study to evaluate the effect of LCZ696 compared to individualized medical therapy for comorbidities in Heart Failure with preserved Ejection Fraction (HFpEF) patientsHeart Failure with preserved Ejection Fraction (HFpEF)MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849EUCTR2016-003410-28-SKovartis Pharma AG2,500