Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. 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.
Conditions
Interventions
Trade Name: Ritalin LA 20mg capsules
Product Name: Methylphenidate modified release 20 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Con
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 Syndrom. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of our study is to determine the efficacy of methylphenidate in reducing fatigue in subjects with Multiple sclerosis. The question of whether MS-associated fatigue improves after 6 weeks of methylphenidate therapy compared to baseline as measeured by Fatigue severity scale comprises the primary objective of our study. ;Secondary Objective: Secondary objectives are to evaluate the efficacy of methylphenidate on fatigue in subjects with MS as measured by MFIS (modified fatigue impact scale) and VAS (visual analogue scale), on quality of life as measured by HAQUAMS (Hamburger Lebensqualitätsfragebogen) and on quality of sleep as measured by Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index. An objetive assessment of fatigue will be done by neuropsychological TAP (test for attentional performance -subscale alertness and divided attention).;Primary end point(s): Improvement (baseline vs. 6 weeks) of fatigue as assessed by Fatigue Severity Scale;Timepoint(s) of evaluation of this end point: Baseline and after six weeks of treatment with study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline and after six weeks of treatment with study medication;Secondary end point(s): Improvement of fatigue (baseline vs. 6 weeks) as assessed by modified fatigue impact scale. Improvement of fatigue (baseline vs. 6 weeks) as assessed by visual analogue scale. Improvement of quality of life (baseline vs. 6 weeks) as assessed by Hamburger Lebensqualitätsfragebogen. Improvement of fatigue as measured (baseline vs. 6 weeks) by neuropsycholgical TAP-testing. Improvement of sleep quality (baseline vs. 6 weeks) as measured by ESS and PSQI | — |
Countries
Austria
Contacts
Public ContactInformationsstelle
Wiener Pflege-,Patientinnen-und Patientenanwaltschaft
Outcome results
None listed