Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis

NCT ID: NCT01879202

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-02-28

Brief Summary

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).

Detailed Description

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).

Conditions

Multiple Sclerosis; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Methylphenidate modified release

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ritalin LA 20mg; Ritalin LA 30mg; Ritalin LA 40mg; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Prof. Fritz Leutmezer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fritz Leutmezer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Neurology

Locations

Medical University of Vienna, Department of Neurology

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Fritz Leutmezer, MD

Role: CONTACT

fritz.leutmezer@meduniwien.ac.at

+43 1 40400 ext. 3120

Facility Contacts

Fritz Leutmezer, MD

Role: primary

fritz.leutmezer@meduniwien.ac.at

+43 1 40400 ext. 3120

Other Identifiers

SSP

Identifier Type: -

Identifier Source: org_study_id