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

NCT01149525 | Completed Phase 3 DMC

• 2 other identifiers: CHUBX 2009/132009-015934-30
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis/complications; Fatigue Syndrome; Chronic/drug therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Fatigue Severity Scale (FSS)

  Three and nine months

• Fatigue Visual Analogic Scale (VAS)

  Three and nine months

• physical dimension scale of MFIS

  Three and nine months

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

  Three and nine months

Study Arms (2)

1

EXPERIMENTAL

oral solution of L-Carnitine, 4g per day

Drug: L-Carnitine

2

PLACEBO COMPARATOR

Similar oral solution without L-Carnitine

Drug: Placebo

Interventions

L-Carnitine DRUG

2g oral solution , twice per day (morning/evening), during 3 months

1

Placebo DRUG

oral solution, twice per day (morning/evening), during 3 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (6)

University Hospital, Hospital Pellegrin

Bordeaux, 33076, France

Location

University Hospital

Fort de France, 97261, France

Location

University Hospital, Hospital Dupuytren

Limoges, 87042, France

Location

University Hospital, Hospital Central

Nancy, 54034, France

Location

University Hospital, Hospital Laënnec

Nantes, 44093, France

Location

University Hospital, Hospital Pasteur

Nice, 06000, France

Location

Related Publications (27)

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Jean-Christophe OUALLET, MD-PhD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Geneviève CHENE, MD-PhD

  USMR (University Hospital, Bordeaux)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 12, 2026

Record last verified: 2017-05

Locations

FR (6)