Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: L-Carnitine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with serious unstable disease : recurrent or serious relapses rapidly ongoing disability impairment in the preceding 6 months serious or non stabilized depression Patients starting a new disease modifying therapy, immunosuppression or antidepressant therapy less than 3 months ago or not stabilized. Patients with a treatment of fatigue or of other condition that may interfere with fatigue evaluation to the appreciation of the neurologist. Energy drinks consumption or toxicomania. 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. Person under protection of the law. Participation in other clinical trials (allowing for exceptions, after recommendation from the scientific council).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>oral solution of L-Carnitine, 4g per day | Drug: L-Carnitine<br>* 2g oral solution , twice per day (morning/evening), during 3 months<br>|
| Placebo Comparator: 2<br>Similar oral solution without L-Carnitine | Drug: Placebo<br>* oral solution, twice per day (morning/evening), during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale (FSS) |  | Three and nine months | 
| Fatigue Visual Analogic Scale (VAS) |  | Three and nine months | 
| physical dimension scale of MFIS |  | Three and nine months | 
| SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french) |  | Three and nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis/complications, Fatigue Syndrome, Chronic/drug therapy