CompletedPhase 3

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

France59 participantsStarted 2010-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).

Timeframe: Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)

Trial details

NCT IDNCT01149525

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Multiple Sclerosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.