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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
L-Carnitine
Placebo
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis/complications, Fatigue Syndrome, Chronic/drug therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Hospital, Hospital Pellegrin
  • University Hospital
  • University Hospital, Hospital Dupuytren
  • University Hospital, Hospital Central
  • University Hospital, Hospital Laënnec
  • University Hospital, Hospital Pasteur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

oral solution of L-Carnitine, 4g per day

Similar oral solution without L-Carnitine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fatigue Severity Scale (FSS)
Fatigue Visual Analogic Scale (VAS)
physical dimension scale of MFIS
SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)

Full Information

First Posted
June 21, 2010
Last Updated
May 5, 2017
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01149525
Brief Title
Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
Acronym
FACTSEP
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis/complications, Fatigue Syndrome, Chronic/drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
oral solution of L-Carnitine, 4g per day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Similar oral solution without L-Carnitine
Intervention Type
Drug
Intervention Name(s)
L-Carnitine
Intervention Description
2g oral solution , twice per day (morning/evening), during 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral solution, twice per day (morning/evening), during 3 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Fatigue Severity Scale (FSS)
Time Frame
Three and nine months
Title
Fatigue Visual Analogic Scale (VAS)
Time Frame
Three and nine months
Title
physical dimension scale of MFIS
Time Frame
Three and nine months
Title
SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)
Time Frame
Three and nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe OUALLET, MD-PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geneviève CHENE, MD-PhD
Organizational Affiliation
USMR (University Hospital, Bordeaux)
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital, Hospital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
University Hospital
City
Fort de France
ZIP/Postal Code
97261
Country
France
Facility Name
University Hospital, Hospital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
University Hospital, Hospital Central
City
Nancy
ZIP/Postal Code
54034
Country
France
Facility Name
University Hospital, Hospital Laënnec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital, Hospital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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

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