Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis (FACTSEP)
5 mei 2017 bijgewerkt door: University Hospital, Bordeaux
A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
59
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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Bordeaux, Frankrijk, 33076
- University Hospital, Hospital Pellegrin
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Fort de France, Frankrijk, 97261
- University Hospital
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Limoges, Frankrijk, 87042
- University Hospital, Hospital Dupuytren
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Nancy, Frankrijk, 54034
- University Hospital, Hospital Central
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Nantes, Frankrijk, 44093
- University Hospital, Hospital Laënnec
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Nice, Frankrijk, 06000
- University Hospital, Hospital Pasteur
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 1
oral solution of L-Carnitine, 4g per day
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2g oral solution , twice per day (morning/evening), during 3 months
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Placebo-vergelijker: 2
Similar oral solution without L-Carnitine
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oral solution, twice per day (morning/evening), during 3 months
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).
Tijdsspanne: Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)
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Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Fatigue Severity Scale (FSS)
Tijdsspanne: Three and nine months
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Three and nine months
|
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Fatigue Visual Analogic Scale (VAS)
Tijdsspanne: Three and nine months
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Three and nine months
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physical dimension scale of MFIS
Tijdsspanne: Three and nine months
|
Three and nine months
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SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)
Tijdsspanne: Three and nine months
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Three and nine months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Geneviève CHENE, MD-PhD, USMR (University Hospital, Bordeaux)
- Hoofdonderzoeker: Jean-Christophe OUALLET, MD-PhD, University Hospital Bordeaux, France
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.
- 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.
- 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.
- Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lebrun C, Alchaar H, Candito M, Bourg V, Chatel M. Levocarnitine administration in multiple sclerosis patients with immunosuppressive therapy-induced fatigue. Mult Scler. 2006 Jun;12(3):321-4. doi: 10.1191/135248506ms1275oa.
- Pittion-Vouyovitch S, Debouverie M, Guillemin F, Vandenberghe N, Anxionnat R, Vespignani H. Fatigue in multiple sclerosis is related to disability, depression and quality of life. J Neurol Sci. 2006 Apr 15;243(1-2):39-45. doi: 10.1016/j.jns.2005.11.025. Epub 2006 Jan 24.
- Debouverie M, Pittion S. [Fatigue and episodic exhaustion as a feature of multiple sclerosis]. Rev Neurol (Paris). 2006 Mar;162(3):295-7. doi: 10.1016/s0035-3787(06)75015-9. No abstract available. French.
- Richardson BA, Flack VF. The analysis of incomplete data in the three-period two-treatment cross-over design for clinical trials. Stat Med. 1996 Jan 30;15(2):127-43. doi: 10.1002/(SICI)1097-0258(19960130)15:23.0.CO;2-D.
- Kieser M, Friede T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Stat Med. 2000 Apr 15;19(7):901-11. doi: 10.1002/(sici)1097-0258(20000415)19:73.0.co;2-l.
- Graziano F, Bisonni R, Catalano V, Silva R, Rovidati S, Mencarini E, Ferraro B, Canestrari F, Baldelli AM, De Gaetano A, Giordani P, Testa E, Lai V. Potential role of levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in non-anaemic cancer patients. Br J Cancer. 2002 Jun 17;86(12):1854-7. doi: 10.1038/sj.bjc.6600413.
- Plioplys AV, Plioplys S. Amantadine and L-carnitine treatment of Chronic Fatigue Syndrome. Neuropsychobiology. 1997;35(1):16-23. doi: 10.1159/000119325.
- Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32. doi: 10.1177/1352458507077942.
- Montel SR, Bungener C. Coping and quality of life in one hundred and thirty five subjects with multiple sclerosis. Mult Scler. 2007 Apr;13(3):393-401. doi: 10.1177/1352458506071170. Epub 2007 Jan 29.
- Cruciani RA, Dvorkin E, Homel P, Malamud S, Culliney B, Lapin J, Portenoy RK, Esteban-Cruciani N. Safety, tolerability and symptom outcomes associated with L-carnitine supplementation in patients with cancer, fatigue, and carnitine deficiency: a phase I/II study. J Pain Symptom Manage. 2006 Dec;32(6):551-9. doi: 10.1016/j.jpainsymman.2006.09.001.
- Gramignano G, Lusso MR, Madeddu C, Massa E, Serpe R, Deiana L, Lamonica G, Dessi M, Spiga C, Astara G, Maccio A, Mantovani G. Efficacy of l-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition. 2006 Feb;22(2):136-45. doi: 10.1016/j.nut.2005.06.003.
- Neri S, Pistone G, Saraceno B, Pennisi G, Luca S, Malaguarnera M. L-carnitine decreases severity and type of fatigue induced by interferon-alpha in the treatment of patients with hepatitis C. Neuropsychobiology. 2003;47(2):94-7. doi: 10.1159/000070016.
- Rebouche CJ. Kinetics, pharmacokinetics, and regulation of L-carnitine and acetyl-L-carnitine metabolism. Ann N Y Acad Sci. 2004 Nov;1033:30-41. doi: 10.1196/annals.1320.003.
- Plioplys AV, Plioplys S. Serum levels of carnitine in chronic fatigue syndrome: clinical correlates. Neuropsychobiology. 1995;32(3):132-8. doi: 10.1159/000119226.
- Cruciani RA, Dvorkin E, Homel P, Culliney B, Malamud S, Shaiova L, Fleishman S, Lapin J, Klein E, Lesage P, Portenoy R, Esteban-Cruciani N. L-carnitine supplementation for the treatment of fatigue and depressed mood in cancer patients with carnitine deficiency: a preliminary analysis. Ann N Y Acad Sci. 2004 Nov;1033:168-76. doi: 10.1196/annals.1320.016.
- Taglialatela G, Navarra D, Cruciani R, Ramacci MT, Alema GS, Angelucci L. Acetyl-L-carnitine treatment increases nerve growth factor levels and choline acetyltransferase activity in the central nervous system of aged rats. Exp Gerontol. 1994 Jan-Feb;29(1):55-66. doi: 10.1016/0531-5565(94)90062-0.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2010
Primaire voltooiing (Werkelijk)
1 maart 2013
Studie voltooiing (Werkelijk)
1 juli 2013
Studieregistratiedata
Eerst ingediend
21 juni 2010
Eerst ingediend dat voldeed aan de QC-criteria
21 juni 2010
Eerst geplaatst (Schatting)
23 juni 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 mei 2017
Laatste update ingediend die voldeed aan QC-criteria
5 mei 2017
Laatst geverifieerd
1 mei 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CHUBX 2009/13
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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