Disabling fatigue in multiple sclerosis occurs frequently: how should it be treated? A randomized clinical trial

Completed (inferred)Not a drug-phase studyEarly (CIS/RIS)ISRCTN82353628

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • 1. Fatigue: Checklist Individual Strength (CIS) subscale fatigue 2. Participation: Impact on Participation and Autonomy (IPA) The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52

    FatiguePhysical function

Other measures (1)

  • 1. Medical Outcome study Short Form 36 (SF36) 2. Rehabilitation Activities Profile (RAP) 3. Fatigue Severity Scale (FSS) 4. Checklist Individual Strength (CIS) subscales motivation, concentration, activity 5. Modified Fatigue Impact Scale (MFIS) The 6 time points are: week -1, week 0, week 8, week 16, week 26 and week 52

    FatiguePhysical functionQuality of life (reported by participants)

Who could take part

Early (CIS/RIS) · 18 to 70

Show the full criteria

Inclusion criteria

Inclusion: Ambulatory multiple sclerosis (MS) patients fulfulling the following enrollment criteria: 1. Age between 18-70 years 2. Diagnosis of MS according to the criteria of McDonald 3. Able to walk with no more than one unilateral walking aid i.e. able to walk with no more than one unilateral walking aid 4. Suffering from fatigue, defined as a score higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS) Exclusion: 1. Patients using in the last three months prior to inclusion amantadine, modafinil, Ritalin® or pemoline for their fatigue 2. Major depression

Exclusion criteria

Not separately supplied in the registry.

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

About this trial

In the sponsor's words

Not provided at time of registration

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2011

    2. Finished

      Apr 2014

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