Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis
Maneno muhimu
Kikemikali
Maelezo
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).
Tarehe
| Imethibitishwa Mwisho: | 04/30/2015 |
| Iliyowasilishwa Kwanza: | 11/06/2012 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 06/12/2013 |
| Iliyotumwa Kwanza: | 06/16/2013 |
| Sasisho la Mwisho Liliwasilishwa: | 05/07/2015 |
| Sasisho la Mwisho Lilichapishwa: | 05/11/2015 |
| Tarehe halisi ya kuanza kwa masomo: | 11/30/2012 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 01/31/2017 |
| Tarehe ya Kukamilisha Utafiti: | 01/31/2017 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Methylphenidate modified release
Drug: Maltodextrin
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Change of Fatigue as measured by Fatigue Severity Scale [Baseline versus follow-up at 6 weeks]
Hatua za Matokeo ya Sekondari
1. Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS) [Baseline versus follow up at 6 weeks]
Hatua Nyingine za Matokeo
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]
