Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Methylphenidate

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