Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
- Registration Number
- NCT01149525
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 18 years old and older
- Relapsing remitting (RR) secondary progressive (SP) or primary progressive multiple sclerosis according to McDonald 2005 (Polman) MS diagnostic criteria.
- Affected of fatigue for more than 3 months with global score on Modified Fatigue Impact Scale (MFIS)>45.
- Indication of treatment of fatigue to the appreciation of the neurologist.
- Expanded Disability Status Scale (EDSS) not exceeding 6.0.
- Information and comprehensive agreement signed by patient and the investigator.
- Subject affiliated to health insurance coverage.
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Patients with serious unstable disease :
- recurrent or serious relapses
- rapidly ongoing disability impairment in the preceding 6 months
- serious or non stabilized depression
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Patients starting a new disease modifying therapy, immunosuppression or antidepressant therapy less than 3 months ago or not stabilized.
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Patients with a treatment of fatigue or of other condition that may interfere with fatigue evaluation to the appreciation of the neurologist.
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Energy drinks consumption or toxicomania.
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All other reasons to the opinion of the neurologist that may impair study management, especially patient compliance, neuro-psychological disorders that may input questionnaires filling.
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Person under protection of the law.
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Participation in other clinical trials (allowing for exceptions, after recommendation from the scientific council).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Placebo Similar oral solution without L-Carnitine 1 L-Carnitine oral solution of L-Carnitine, 4g per day
- Primary Outcome Measures
Name Time Method Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French). Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)
- Secondary Outcome Measures
Name Time Method SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french) Three and nine months physical dimension scale of MFIS Three and nine months Fatigue Severity Scale (FSS) Three and nine months Fatigue Visual Analogic Scale (VAS) Three and nine months
Trial Locations
- Locations (6)
University Hospital, Hospital Pasteur
🇫🇷Nice, France
University Hospital, Hospital Laënnec
🇫🇷Nantes, France
University Hospital, Hospital Pellegrin
🇫🇷Bordeaux, France
University Hospital
🇫🇷Fort de France, France
University Hospital, Hospital Dupuytren
🇫🇷Limoges, France
University Hospital, Hospital Central
🇫🇷Nancy, France