Status:
COMPLETED
Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01149525
Start Date
June 1 2010
End Date
July 1 2013
Last Update
May 8 2017
Active Locations (6)
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1
University Hospital, Hospital Pellegrin
Bordeaux, France, 33076
2
University Hospital
Fort de France, France, 97261
3
University Hospital, Hospital Dupuytren
Limoges, France, 87042
4
University Hospital, Hospital Central
Nancy, France, 54034