Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis
关键词
抽象
描述
The management oft fatigue comprises nonpharmacologic approaches like exercise, cooling procedures, nutrition, and energy conservation programmes. These strategies should be considered as first-line options since they add to overall wellbeing, have no side effects and increase the patient's autonomy. However, in most cases these strategies will not suffice to keep the patient symptom free on the long term. Also, patients with overwhelming and severe fatigue will be unlikely to engage in exercise. In these cases adding pharmacologic therapy will be the next step. Until now, Amantadine, Modafinil, and Pemoline have been used among others, with some success. Also antidepressants like buprione, fluoxetine, and venlafaxine have been used although they have never been systematically studied for the management of MS-related fatigue. However, if a mood disorder is present, it is appropriate to treat it before pursuing pharmacologic therapy of fatigue. Nevertheless, the response rate of all pharmacologic therapies of MS-related fatigue is not totally convincing making alternative pharmacologic therapies furthermore desirable. Methylphenidate is an antagonist of dopamine and norepinephrine transporters on the presynaptic neuronal cell membrane. Reduced reuptake results in an increase in extracellular levels of both neurotransmitters. Until now, methylphenidate has been successfully used to treat fatigue in HIV and parkinson´s disease, data on its efficacy in MS are not available. The aim of this study is to determine the efficacy of methylphenidate treatment in MS-associated fatigue. The treatment phase will be 6 weeks and treatment efficacy will be measured by validated questionnaires (Fatigue Severity Scale FSS, modified Fatigue Impact Scale MFIS) and by a neuropsychological test (Test for Attentional Performance).
日期
| 最后验证: | 04/30/2015 |
| 首次提交: | 11/06/2012 |
| 提交的预估入学人数: | 06/12/2013 |
| 首次发布: | 06/16/2013 |
| 上次提交的更新: | 05/07/2015 |
| 最近更新发布: | 05/11/2015 |
| 实际学习开始日期: | 11/30/2012 |
| 预计主要完成日期: | 01/31/2017 |
| 预计完成日期: | 01/31/2017 |
状况或疾病
干预/治疗
Drug: Methylphenidate modified release
Drug: Maltodextrin
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Methylphenidate modified release The active agents is racemic methylphenidate hydrochloride, modified release, a mild central nervous system stimulant (pharmacotherapeutic group: psychostimulants). Study medication will be taken once daily. Initially patients will be provided with 20mg and 30mg capsules of study medication. They are instructed to take 20mg within the first week and within the second week 30mg capsules. Visit 2 is scheduled two weeks after baseline and at Visit 2 patients will be provided with 40mg capsules and instructed to take them for the rest of the study. | Drug: Methylphenidate modified release Ritalin 20mg once daily within the first week, Ritalin 30mg once daily within the second week and afterwards Ritalin 40mg will be taken once daily throughout the remaining active treatment phase. |
| Placebo Comparator: Maltodextrin Study medication has to be taken once daily. Initially patients will be provided with 20mg and 30mg capsules of study medication. They are instructed to take 20mg within the first week and within the second week 30mg capsules. Visit 2 is scheduled two weeks after baseline and at Visit 2 patients will be provided with 40mg capsules and instructed to take them for the rest of the study. | Drug: Maltodextrin Study medication will be taken once daily. Patients will take 20mg of study medication within the first week, 30mg within the second week and afterwards 40mg of study medication throughout the remaining active study period. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Diagnosis of multiple sclerosis according to McDonalds criteria. - Age > 18 years - Fatigue as measured by Fatigue Severity Scale - Signed informed consent Exclusion Criteria: - Known allergy or hypersensitivity to Methylphenidate or any of its ingredients - Marked anxiety, tension and agitation - Patients with glaucoma or hyperthyroidism - Patients with motor-tics, a family history or diagnosis of Tourette´s syndrome - 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 life-threatening arrhythmias and channelopathies. - History of drug dependence or alcoholism - History of seizures - Pregnant women or females of childbearing potential who want to become pregnant within the study period. - Severe psychiatric disorders - Change of any medication treatment <8 weeks before starting the study - Participation in any other clinical trial at the same time |
结果
主要结果指标
1. Change of Fatigue as measured by Fatigue Severity Scale [Baseline versus follow-up at 6 weeks]
次要成果指标
1. Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS) [Baseline versus follow up at 6 weeks]
其他成果措施
1. Change of Quality of life as assessed by Hamburger Lebensqualitätsfragebogen (HAQUAMS) [Baseline versus follow up at 6 weeks]
2. Fatigue as measured by TAP (Test for Attentional Performance) [Baseline, after 6 weeks]
3. Quality of sleep as measured by Epworth Sleepiness Scale (ESS) [Baseline, after 6 weeks]
4. Quality of sleep as measured by Pittsburgh Sleep Quality Index [Baseline, after 6 weeks]
