Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis

Medical University of Vienna96 enrolled

Overview

Fatigue is a common symptom in multiple sclerosis (MS) that is characterized by physical and/or mental exhaustion. Fatigue is difficult to treat and treatment efficacy of available therapy is limited. The goal of this study is to determine whether MS-associated fatigue improves after 6 weeks of methylphenidate therapy. Treatment efficacy will be measured by a questionnaire called "Fatigue Severity Scale" (FSS).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis Fatigue

Interventions

Methylphenidate modified releaseDRUG

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.

MaltodextrinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna, Department of Neurology

Vienna, State of Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

Change of Fatigue as measured by Fatigue Severity Scale

The Fatigue severity scale is one of the most commonly used self questionnaires to measure fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. A low value (e.g., 1); indicates strong disagreement with the statement, whereas a high value (e.g., 7); indicates strong agreement. A total score of 36 or more suggests presence of fatigue.

Time frame: Baseline versus follow-up at 6 weeks

Secondary Outcomes

Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS)

This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. All items are scaled so that higher scores indicate a greater impact of fatigue on a patient's activities

Time frame: Baseline versus follow up at 6 weeks

Central Contacts

Fritz Leutmezer, MD

CONTACT

+43 1 40400 fritz.leutmezer@meduniwien.ac.at

Data from ClinicalTrials.gov

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