The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in a cross-over design. This study is sponsored by academic French health institutions.
Fatigue is one of the most frequent disabling symptom in Multiple Sclerosis (MS). L-Carnitine is currently used in the symptomatic treatment of fatigue after chemotherapy in patients with cancers. It is also empirically used by numerous MS centers in the treatment of fatigue. However, this practice is not evidence-based (Cochrane review 2010). This study will evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in MS patients in a randomized double blind national multicenter cross-over trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
2g oral solution , twice per day (morning/evening), during 3 months
oral solution, twice per day (morning/evening), during 3 months
University Hospital, Hospital Pellegrin
Bordeaux, France
University Hospital
Fort de France, France
University Hospital, Hospital Dupuytren
Limoges, France
University Hospital, Hospital Central
Nancy, France
Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).
Time frame: Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)
Fatigue Severity Scale (FSS)
Time frame: Three and nine months
Fatigue Visual Analogic Scale (VAS)
Time frame: Three and nine months
physical dimension scale of MFIS
Time frame: Three and nine months
SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)
Time frame: Three and nine months
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University Hospital, Hospital Laënnec
Nantes, France
University Hospital, Hospital Pasteur
Nice, France