Clinical trial NCT01149525: Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
Official title: A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis/complications
Fatigue Syndrome
Chronic/drug therapy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).
timeFrame: Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Three and nine months
measure: Fatigue Visual Analogic Scale (VAS)
timeFrame: Three and nine months
measure: physical dimension scale of MFIS
timeFrame: Three and nine months
measure: SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)
timeFrame: Three and nine months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Hospital Pellegrin
city: Fort de France
country: France
facility: University Hospital
city: Limoges
country: France
facility: University Hospital, Hospital Dupuytren
city: Nancy
country: France
facility: University Hospital, Hospital Central
city: Nantes
country: France
facility: University Hospital, Hospital Laënnec
city: Nice
country: France
facility: University Hospital, Hospital Pasteur
Study officials:
affiliation: University Hospital Bordeaux, France
name: Jean-Christophe OUALLET, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USMR (University Hospital, Bordeaux)
name: Geneviève CHENE, MD-PhD
role: STUDY_CHAIR
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