EUCTR2012-003418-15-AT进行中（未招募）1 期
Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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
- •Diagnosis of multiple sclerosis (relapsing remitting, progressive
- •courses) according to McDonalds criteria.
- •Age > 18years
- •Fatigue as measured by Fatigue Severity Scale
- •Signed informed consent
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Known allergy or hypersensitivity to Methylphenidate or any of its
- •ingredients.
- •Marked anxiety, tension and agitation.
- •Patients with glaucoma or hyperthyreodism.
- •Patients with motor-tics, a family history or diagnosis of Tourette´s
- •Treatment with monoamine oxidase inhibitors, also within a
- •minimum of 14 days following discontinuation (hypertensive crisis may result).
- •Phaeochromocytoma.
- •Pre-existing cardiovascular disorders including severe hypertension, angina, arterial occlusive disorder, heart failure, haemodynamically significant congenital heart disease,
- •cardiomyopathies, myocardial infarction, potentially lifethreatening
- •arrhythmias and channelopathies.
- •History of drug dependence or alcoholism.
- •History of seizures.
- •Severe psychiatric disorders.
- •Pregnant women or females of childbearing potential who want to become pregnant within the study period.
- •Change of any medication treatment <8 weeks before starting the study
- •Participation in any other clinical trial at the same time
研究者
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