Methylphenidate modified release as treatment of MS-associated fatigue.

Phase 1

• Conditions: Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003418-15-AT
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-09
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Diagnosis of multiple sclerosis (relapsing remitting, progressive
courses) according to McDonalds criteria.
• Age > 18years
• Fatigue as measured by Fatigue Severity Scale
• Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Known allergy or hypersensitivity to Methylphenidate or any of its
ingredients.
Marked anxiety, tension and agitation.
Patients with glaucoma or hyperthyreodism.
Patients with motor-tics, a family history or diagnosis of Tourette´s
Syndrom.
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 lifethreatening
arrhythmias and channelopathies.
History of drug dependence or alcoholism.
History of seizures.
Severe psychiatric disorders.
Pregnant women or females of childbearing potential who want to become pregnant within the study period.
Change of any medication treatment <8 weeks before starting the study
Participation in any other clinical trial at the same time

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified