Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis; Fatigue
Intervention: Methylphenidate modified release (Drug); Maltodextrin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Fritz Leutmezer, MD, Principal Investigator, Affiliation: Medical University of Vienna, Department of Neurology
Overall contact: Fritz Leutmezer, MD, Phone: +43 1 40400, Ext: 3120, Email: fritz.leutmezer@meduniwien.ac.at
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).
Clinical Details
Official title: Methylphenidate Modified-release as Treatment of MS-associated Fatigue. A Single-center Randomized Double-blind Placebo-controlled Study.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change of Fatigue as measured by Fatigue Severity Scale
Secondary outcome: Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Fritz Leutmezer, MD, Phone: +43 1 40400, Ext: 3120, Email: fritz.leutmezer@meduniwien.ac.at
Medical University of Vienna, Department of Neurology, Vienna 1090, Austria; Recruiting Fritz Leutmezer, MD, Phone: +43 1 40400, Ext: 3120, Email: fritz.leutmezer@meduniwien.ac.at Fritz Leutmezer, MD, Principal Investigator
Additional Information
Starting date: December 2012
Last updated: May 8, 2015
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