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

What Was Tested

This registered phase 3 trial tested L-Carnitine for multiple sclerosis.

This study will randomize 60 patients in a cross-over design.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Similar oral solution without L-Carnitine.

The registry classes the interventions as drug.

More on the Plan

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).

Who Took Part

Enrollment: 59 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: patients with serious unstable disease :; recurrent or serious relapses; rapidly ongoing disability impairment in the preceding 6 months.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

In the crossover set-up each of the multiple sclerosis participants took both L-Carnitine and the comparison in turn, acting as their own control.

Blinding on both sides kept the multiple sclerosis participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant and investigator.

It started in 2010-06 with completion listed for 2013-03.

It ran at 6 sites in France (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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)).

It also tracked 4 secondary outcomes, for example Fatigue Severity Scale (FSS), Fatigue Visual Analogic Scale (VAS), physical dimension scale of MFIS and SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 59 people with multiple sclerosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Multiple sclerosis research.