A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 12
- 主要终点
- Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)>
- •Indication of treatment of fatigue to the appreciation of the neurologist.
- •Expanded Disability Status Scale (EDSS) not exceeding 6.
- •Information and comprehensive agreement signed by patient and the investigator.
- •Subject affiliated to health insurance coverage.
排除标准
- •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).
研究组 & 干预措施
1
oral solution of L-Carnitine, 4g per day
干预措施: L-Carnitine (Drug)
2
Similar oral solution without L-Carnitine
干预措施: Placebo (Drug)
结局指标
主要结局
Global score on the 21 item Modified Fatigue Impact Scale (MFIS, translated and validated in French).
时间窗: Three months and nine months (2 periods of 3 months on treatment/placebo separated by a wash-out period of 3 months)
次要结局
- SEP59 scale of quality of life (Multiple Sclerosis Quality Of Life scale validated in french)(Three and nine months)
- physical dimension scale of MFIS(Three and nine months)
- Fatigue Severity Scale (FSS)(Three and nine months)
- Fatigue Visual Analogic Scale (VAS)(Three and nine months)