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

Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: L-Carnitine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital, Bordeaux

Official(s) and/or principal investigator(s):
Jean-Christophe OUALLET, MD-PhD, Principal Investigator, Affiliation: University Hospital Bordeaux, France
Geneviève CHENE, MD-PhD, Study Chair, Affiliation: USMR (University Hospital, Bordeaux)

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).

Secondary outcome:

Fatigue Severity Scale (FSS)

Fatigue Visual Analogic Scale (VAS)

physical dimension scale of MFIS

SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

University Hospital, Hospital Pellegrin, Bordeaux 33076, France

University Hospital, Fort de France 97261, France

University Hospital, Hospital Dupuytren, Limoges 87042, France

University Hospital, Hospital Central, Nancy 54034, France

University Hospital, Hospital Laënnec, Nantes 44093, France

University Hospital, Hospital Pasteur, Nice 06000, France

Additional Information

Related publications:

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. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD007280.

Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. Review.

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.

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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.

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Starting date: June 2010
Last updated: November 5, 2013

Page last updated: August 23, 2015

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