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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44334
Enrollment
30
Registered
2018-05-04
Start date
2018-12-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsing-remitting multiple sclerosis

Interventions

Twee-minute contraction with the index finger abductor muscle.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Association between fatigue (as measured with the FSS questionnaire) and measures of fatigability (changes in index finger abductor force and voluntary activation) in pwRRMS after 16 weeks of Tecfidera medication.

Secondary

MeasureTime frame
Secondary study parameters are: 1. changes in the decline in voluntary, electrically evoked force and muscle activation during the fatiguing task (fatigability measures), and 2. changes in FSS scores after 16 weeks of Tecfidera medication (fatigue measures).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)