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

University Hospital of Bordeaux

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Placebo

Drug: L-Carnitine

Study type

Interventional

Funder types

Other

Identifiers

NCT01149525

CHUBX 2009/13

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).