Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in
A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- L-Carnitine
Placebo
- Placebo
What it measured
Main measures
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)
FatigueLe critère de jugement principal est le score global au Modified Fatigue Impact Scale (MFIS) qui permet d’évaluer la fatigue (cf.annexe 5). Il sera mesuré en insu du traitement reçu au début de l’étude puis tous les mois jusqu’à la fin de l’étude. Cette échelle détaillée et multidimentionelle est largement utilisée dans les études publiées et la seul validée en langue française. L’utilisation des
Fatigue
Other measures (4)
Fatigue Severity Scale (FSS)
Three and nine months
FatigueFatigue Visual Analogic Scale (VAS)
Three and nine months
Fatiguephysical dimension scale of MFIS
Three and nine months
FatigueSEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)
Three and nine months
Quality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 and over
Show the full 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).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2.Background
Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.Background
Filippi M, Rocca MA, Colombo B, Falini A, Codella M, Scotti G, Comi G. Functional magnetic resonance imaging correlates of fatigue in multiple sclerosis. Neuroimage. 2002 Mar;15(3):559-67. doi: 10.1006/nimg.2001.1011.Background
Oken BS, Kishiyama S, Zajdel D, Bourdette D, Carlsen J, Haas M, Hugos C, Kraemer DF, Lawrence J, Mass M. Randomized controlled trial of yoga and exercise in multiple sclerosis. Neurology. 2004 Jun 8;62(11):2058-64. doi: 10.1212/01.wnl.0000129534.88602.5c.Background
Pucci E, Branas P, D'Amico R, Giuliani G, Solari A, Taus C. Amantadine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD002818. doi: 10.1002/14651858.CD002818.pub2.Background
Krupp LB, Coyle PK, Doscher C, Miller A, Cross AH, Jandorf L, Halper J, Johnson B, Morgante L, Grimson R. Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo. Neurology. 1995 Nov;45(11):1956-61. doi: 10.1212/wnl.45.11.1956.Background
van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.Background
Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.Background
Tomassini V, Pozzilli C, Onesti E, Pasqualetti P, Marinelli F, Pisani A, Fieschi C. Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial. J Neurol Sci. 2004 Mar 15;218(1-2):103-8. doi: 10.1016/j.jns.2003.11.005.Background
Wingerchuk DM, Benarroch EE, O'Brien PC, Keegan BM, Lucchinetti CF, Noseworthy JH, Weinshenker BG, Rodriguez M. A randomized controlled crossover trial of aspirin for fatigue in multiple sclerosis. Neurology. 2005 Apr 12;64(7):1267-9. doi: 10.1212/01.WNL.0000156803.23698.9A.
Loading reviews and guidelines…
History
Started
Jun 2010
Main results due
Mar 2013
Finished
Jul 2013