Overview

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).