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Multiple SclerosisPhase 3FACTSEPNCT01149525

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

A Phase 3 study testing L-Carnitine in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
L-Carnitine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
6 sitesFrance
Study dates
Jun 2010to Jul 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • University Hospital, Hospital Pellegrin

    Bordeaux, 33076

  • University Hospital

    Fort de France, 97261

  • University Hospital, Hospital Dupuytren

    Limoges, 87042

  • University Hospital, Hospital Central

    Nancy, 54034

  • University Hospital, Hospital Laënnec

    Nantes, 44093

  • University Hospital, Hospital Pasteur

    Nice, 06000

Other trials in France

About this study

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

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.

Read the 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.

Being tested
L-Carnitine, Placebo
Keywords
Multiple Sclerosis/complications, Fatigue Syndrome, Chronic/drug therapy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-CarnitineDrug

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

  • PlaceboDrug

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

Study groups in NCT01149525
Study groupRoleWhat they receive
1Experimentaloral solution of L-Carnitine, 4g per day
Receives: Drug: L-Carnitine
2Placebo comparatorSimilar oral solution without L-Carnitine
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

  1. Fatigue Severity Scale (FSS)

    Measured: Three and nine months

  2. Fatigue Visual Analogic Scale (VAS)

    Measured: Three and nine months

  3. physical dimension scale of MFIS

    Measured: Three and nine months

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

    Measured: Three and nine months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionMar 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01149525
Sponsor's protocol ID
CHUBX 2009/13
Other IDs
2009-015934-30, 2009
Acronym
FACTSEP
Status last verified
May 2017
First submitted
21 Jun 2010
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 20166093

  • Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.

    PubMed 12814166

  • 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.

    PubMed 11848698

  • 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.

    PubMed 15184614

  • 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.

    PubMed 17253480

  • 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.

    PubMed 7501140

  • 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.

    PubMed 1510353

  • 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.

    PubMed 15824337

  • 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.

    PubMed 14759641

  • 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.

    PubMed 15824361

  • 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.

    PubMed 16764345

  • 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.

    PubMed 16434057

  • 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.

    PubMed 16585884

  • 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.

    PubMed 8614750

  • GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.

    PubMed 14338679

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing L-Carnitine in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01149525, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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