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

NCT ID: NCT01149525

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

oral solution of L-Carnitine, 4g per day

Group Type: EXPERIMENTAL

L-Carnitine

Intervention Type: DRUG

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

2

Similar oral solution without L-Carnitine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

L-Carnitine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Christophe OUALLET, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Geneviève CHENE, MD-PhD

Role: STUDY_CHAIR

USMR (University Hospital, Bordeaux)

Locations

University Hospital, Hospital Pellegrin

Bordeaux, , France

University Hospital

Fort de France, , France

University Hospital, Hospital Dupuytren

Limoges, , France

University Hospital, Hospital Central

Nancy, , France

University Hospital, Hospital Laënnec

Nantes, , France

University Hospital, Hospital Pasteur

Nice, , France

Countries

France

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Other Identifiers

CHUBX 2009/13

Identifier Type: -

Identifier Source: org_study_id