Status:
UNKNOWN
Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis
Lead Sponsor:
Medical University of Vienna
Conditions:
Multiple Sclerosis
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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....
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 o...
Eligibility Criteria
Inclusion
- Diagnosis of multiple sclerosis according to McDonalds criteria.
- Age \> 18 years
- Fatigue as measured by Fatigue Severity Scale
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2017
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01879202
Start Date
December 1 2012
End Date
February 1 2017
Last Update
May 12 2015
Active Locations (1)
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1
Medical University of Vienna, Department of Neurology
Vienna, Vienna, Austria, 1090