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van CCT (UK)

van CCT (UK)

Tecfidera and Fatigue and fatigability in RRMS

- candidate number28290
- NTR NumberNTR7203
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2017
- Secondary IDsUMCG-2017--367 
- Public TitleTecfidera and Fatigue and fatigability in RRMS
- Scientific TitleEffect of dimethyl fumarate (Tecfidera) on the association between fatigue and fatigability in relapsing-remitting MS patients’
- hypothesis
- Healt Condition(s) or Problem(s) studiedFatigue, Fatigability, Dimethyl fumarate , Relapsing-remitting multiple sclerosis (RRMS)
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Informed consent
• Age: 18 – 55 years
• Adequate hand function that allows subjects to utilize the force transducer (as determined by the neurologist)

Additional inclusion criteria for pwRRMS:
• Newly initiating treatment with DMF (Tecfidera) under routine clinical care
• A diagnosis of RRMS according to the McDonald criteria
• A baseline Expanded Disability Status Scale <4.5
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-mei-2020
- Target number of participants20
- Interventions2-minute sustained index finger abduction
- Primary outcomeDescription of the association between measures of fatigability and fatigue in pwRRMS after 16 weeks of treatment with dimethyl fumarate (Tecfidera).
- Secondary outcome1) Description of the effect of 16-week treatment with DMF on fatigue as quantified with the Fatigue severity scale (FSS) in pwRRMS. 2) Description of the effect of 16-week treatment with DMF on fatigability as quantified by a decline in muscle force and changes in voluntary drive in relapsing-remitting MS patients. 3) determination of the repeatability of the measurements in control subjects.
- Timepointsexperimental measurements are performed 2 weeks before treatment with DMF; at the start and after 4 and 16 weeks of treatment.
- Trial web site
- status[default]
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Biogen Nederland
- Publications
- Brief summaryFatigue is an important symptom in persons with relapsing-remitting multiple sclerosis (pwRRMS) which negatively affects quality of life. Fatigue is a self-reported symptom quantified with questionnaires. In previous studies (6, 7) we showed that fatigue is strongly associated with force decline (normalised for maximal force and mood) during a fatiguing task. This opens the possibility to use force decline as a means to objectify fatigue. Dimethylfumarate (DMF) is a first-line oral MS drug prescribed by neurologists as disease modifying therapy for pwRRMS. It is the aim of this study to investigate the association between fatigue and fatigability in pwRRMS starting with DMF medication.
- Main changes (audit trail)
- RECORD1-dec-2017 - 16-mei-2018

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