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

May 5, 2017 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • University Hospital, Hospital Pellegrin
      • Fort de France, France, 97261
        • University Hospital
      • Limoges, France, 87042
        • University Hospital, Hospital Dupuytren
      • Nancy, France, 54034
        • University Hospital, Hospital Central
      • Nantes, France, 44093
        • University Hospital, Hospital Laënnec
      • Nice, France, 06000
        • University Hospital, Hospital Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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

Outcome Measure
Time Frame
Fatigue Severity Scale (FSS)
Time Frame: Three and nine months
Three and nine months
Fatigue Visual Analogic Scale (VAS)
Time Frame: Three and nine months
Three and nine months
physical dimension scale of MFIS
Time Frame: Three and nine months
Three and nine months
SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)
Time Frame: Three and nine months
Three and nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Geneviève CHENE, MD-PhD, USMR (University Hospital, Bordeaux)
  • Principal Investigator: Jean-Christophe OUALLET, MD-PhD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2009/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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