Effect of dimethyl fumarate (Tecfidera) on the association between fatigue and fatigability in relapsing-remitting MS patients*

Completed

• Conditions: relapsing-remitting multiple sclerosis; 10007951

• Registration Number: NL-OMON44334
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

* Informed consent
* Age: 18 * 55 years
Additional criteria for pwRRMS:
* A diagnosis of RRMS according to the McDonald criteria
* A baseline Expanded Disability Status Scale <4.5
* Newly initiating treatment with DMF (Tecfidera) under routine clinical care
* Adequate hand function that allows subjects to utilize the force transducer (as determined by the neurologist).

Exclusion Criteria

* History of alcohol or drug abuse or current alcohol or drug abuse
* Neurologic condition unrelated to MS Psychiatric disorder (including affective disorders).
* Other conditions/diseases influencing fatigue:
o Chronic fatigue syndrome
* Primary immunodeficiency.
* Treatment with steroids within one month prior to inclusion
* Participation in an investigational drug study within 3 months prior to inclusion
* A MS relapse within one month prior to inclusion
* Medication:
o 4-aminopyridine or another form of fampridine
o antidepressant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Association between fatigue (as measured with the FSS questionnaire) and<br /><br>measures of fatigability (changes in index finger abductor force and voluntary<br /><br>activation) in pwRRMS after 16 weeks of Tecfidera medication.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are: 1. changes in the decline in voluntary,<br /><br>electrically evoked force and muscle activation during the fatiguing task<br /><br>(fatigability measures), and 2. changes in FSS scores after 16 weeks of<br /><br>Tecfidera medication (fatigue measures).</p><br>