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NCT Number: NCT01149525

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Hospital Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

L-carnitine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Fatigue Severity Scale (FSS)

    Time frame: Three and nine months

  2. Fatigue Visual Analogic Scale (VAS)

    Time frame: Three and nine months

  3. physical dimension scale of MFIS

    Time frame: Three and nine months

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

    Time frame: Three and nine months

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

Acronym: FACTSEP

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2010
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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