EUCTR2018-000692-32-IT进行中（未招募）1 期
EFFICACY OF METFORMIN ON MOTILITY AND STRENGTH IN MYOTONIC DYSTROPHY TYPE 1. A randomized, double blind, placebo-controlled, multicenter clinical trial. - MetMyd
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA0 个研究点目标入组 194 人开始时间: 2020年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion criteria are as stated below:
- •Principal inclusion criteria
- •-Male or female patients, aged between 18 and 64 years
- •-A diagnosis of DM1, confirmed by genetic testing, with a CTG expansion size >100
- •-MIRS score 3 or 4
- •-Ambulatory, able to perform the 6 Minute Walk Test (6MWT)
- •-Able to provide written informed consent
- •-For women of child-bearing potential, blood screening for beta-HCG before randomization and use of one effective method of birth control during the conduct of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 194
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria are as stated below:
- •Principal exclusion criteria
- •-Any medical contraindications to metformin including: known hypersensitivity to Metformin Hydrochloride or any of the other
- •ingredients; Renal disease or renal dysfunction (serum creatinine levels =1.5 mg/dL [males], =1.4 mg/dL [females] or abnormal creatinine
- •clearance, < 60 ml/min); Any acute condition which can lead to renal dysfunction (severe infection or injury, dehydration, shock); Heart
- •complications such as heart failure (even if the condition is under control) or recent heart attack; Respiratory failure (patients with nocturnal non-invasive ventilation CPAP or BiPAP could be included); Liver disease; Excessive alcohol intake within 12 months from enrollment; Acute or chronic metabolic acidosis; Diabetic complications such as diabetic coma and ketoacidosis
- •-Symptomatic insulin-requiring diabetes or type 2 diabetes requiring oral anti-diabetic agents
- •-Any history of malignancy except for cases of remission > 12 months
- •-Women who are pregnant or breast-feeding
- •-Chronic administration of any drugs that may interfere with the actions of Metformin.
- •-Participation in another experimental therapeutic protocol within 6 months prior to baseline and during the study period (participation in natural history study is allowed)
- •-Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude
- •the patient from successful completion of the study or would impair interpretation of results
- •-Any neurological disease with motor impairment or other neuromuscular disease than DM1
研究者
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