Multiple Sclerosis | Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis
Multiple Sclerosis research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Methylphenidate modified releaseRitalin 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.
Drug:MaltodextrinStudy 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Methylphenidate modified releaseThe 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.
MaltodextrinStudy 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.
Start Date: December 2012
Completed Date: February 2017
Phase: Phase 2
Primary Outcome: Change of Fatigue as measured by Fatigue Severity Scale
Secondary Outcome: Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
Study sponsors, principal investigator, and references
Principal Investigator: Fritz Leutmezer, MD
Lead Sponsor: Medical University of Vienna