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

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ClinicalTrials.gov Identifier: NCT01149525
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: L-Carnitine Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
oral solution of L-Carnitine, 4g per day
Drug: L-Carnitine
2g oral solution , twice per day (morning/evening), during 3 months

Placebo Comparator: 2
Similar oral solution without L-Carnitine
Drug: Placebo
oral solution, twice per day (morning/evening), during 3 months




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149525


Locations
France
University Hospital, Hospital Pellegrin
Bordeaux, France, 33076
University Hospital
Fort de France, France, 97261
University Hospital, Hospital Dupuytren
Limoges, France, 87042
University Hospital, Hospital Central
Nancy, France, 54034
University Hospital, Hospital Laënnec
Nantes, France, 44093
University Hospital, Hospital Pasteur
Nice, France, 06000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Jean-Christophe OUALLET, MD-PhD University Hospital Bordeaux, France
Study Chair: Geneviève CHENE, MD-PhD USMR (University Hospital, Bordeaux)

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01149525     History of Changes
Other Study ID Numbers: CHUBX 2009/13
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Bordeaux:
Multiple Sclerosis/complications
Fatigue Syndrome
Chronic/drug therapy

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Pharmaceutical Solutions