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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Pharmaceutical Solutions

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).