EVALUATION OF THE EFFICACY AND SAFETY OF METFORMIN IN THE MYOTONIC DYSTROPHY TYPE I (STEINERT’S DISEASE). PHASE III PROSPECTIVE, MULTICENTRE, RANDOMISED, DOUBLE-BLIND CONTROLLED STUDY. - APHP220832

Assistance Publique Hopitaux De Paris0 个研究点目标入组 142 人开始时间: 2024年3月19日最近更新: 2024年7月22日

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•DM1 disease confirmed by genetic analysis, Men and women between 18 and 70 years of age, Preserved walking abilities (stick assistance possible), MIRS (Muscular Impairment Rating Scale) 3 or 4, Women of childbearing potential under efficient contraception during treatment and up to 2 days after the end of the experimental treatment, Ability to provide signed informed consent, Capacity of the patient to understand French language or presence of a relative (or the medical team) who can help the patient understand the study., Affiliation to a social security system

•Diabetic patient, Patient already taking metformin, Pregnant or breast-feeding women, Men with an intention to conceive a child during the time of the study, Contraindications to Metformin: o All types of acute metabolic acidosis o Acute conditions that may impair renal function, such as: dehydration, severe infection, shock o Hepatocellular insufficiency, acute alcohol intoxication, alcoholism o Hypersensitivity to metformin or to one of the excipients o Acute disease that may lead to tissue hypoxia such as decompensated heart failure, acute respiratory failure, recent myocardial infarction. - Respiratory contraindications: o Patient requiring tracheotomy or o Patient requiring non-invasive-ventilation: - more than 12 hours per day - insufficiently ventilated, Creatinine clearance inferior to 60 ml/min (MDRD)., Cardiac contraindications: o Left ventricular ejection fraction below 35% o Conduction system disease on the electrocardiogram with PR interval >200 ms or QRS duration >110 ms without a pacemaker or an implantable defibrillator or cardiac electrophysiological study performed over the past 5 years o Third-degree or Second degree type II atrioventricular block without a pacemaker or an implantable defibrillator o Sustained ventricular tachycardia o Acute cardiac failure o Myocardial infarction of less than three months, Patient participating in another interventional clinical trial, Patient under legal protection (curatorship, tutorship)

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