Status unknownPhase 2MS (type not specified)NCT01879202

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Methylphenidate

    Dopamine transporter inhibitor|Norepinephrine transporter inhibitor

Placebo or sham

  • Maltodextrin

What it measured

Main measures

  • Change of Fatigue as measured by Fatigue Severity Scale

    Baseline versus follow-up at 6 weeks

    Fatigue

Other measures (1)

  • Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS)

    Baseline versus follow up at 6 weeks

    Thinking and memoryFatigue

Who could take part

MS (type not specified) · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

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History

    1. Started

      Dec 2012

    2. Main results due

      Feb 2017

    3. Finished

      Feb 2017

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