This trial is active, not recruiting.

Condition multiple sclerosis
Treatments l-carnitine, placebo
Phase phase 3
Sponsor University Hospital, Bordeaux
Start date June 2010
End date March 2013
Trial size 60 participants
Trial identifier NCT01149525, CHUBX 2009/13


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
oral solution of L-Carnitine, 4g per day
2g oral solution , twice per day (morning/evening), during 3 months
(Placebo Comparator)
Similar oral solution without L-Carnitine
oral solution, twice per day (morning/evening), during 3 months

Primary Outcomes

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)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Principal investigator Jean-Christophe OUALLET, MD-PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.