ACTRN12624000781549尚未招募3 期
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study Assessing the Efficacy and Safety of L-carnitine Supplementation to Treat Muscle Fatigue and Weakness in Children with Neurofibromatosis Type 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 8 Years 至 17 Years（—）
- 性别
- All
入选标准
- •1.Patients aged 8 to 12 years and 13-17 years of age in the expanded age range, in the event of recruitment difficulty who fulfill the National Institutes of Health Consensus Conference diagnostic criteria for NF1 who have a self-reported history of muscle weakness will be invited to participate and
- •2.Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
排除标准
- •1.Have a severe cognitive impairment.
- •2.Unable to understand the PICF, and the study including requirements, benefits, and risks even with the assistance of an interpreter or a translator
- •3.Seizures
- •4.Skeletal abnormalities, e.g., tibial bowing and pseudarthrosis, acute foot or lower limb injuries, e.g., fracture and ankle sprain
- •5.Incapacity to comply with a research protocol, e.g., prolonged absence.
- •6.Have taken carnitine within the last month before commencing the study.
研究者
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