[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steinerts-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steinerts-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100480194","phase-3-evaluation-of-the-efficacy-and-safety-of-metformin-in-the-myotonic-dystrophy-type-1-steinerts-disease-100480194",false,"NCT05532813","Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease)","Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease). A Phase III, Prospective, Multicentre, Randomized, Double-blind Controlled Study","METFORMYO","Inclusion Criteria:\n\n* DM1 disease confirmed by genetic analysis\n* Men and women between 18 and 70 years of age.\n* Preserved walking abilities (stick assistance possible)\n* MIRS score 3 or 4\n* Women of childbearing potential under efficient contraception during treatment\n* Patient able to consent\n* All patients who have completed and signed the specific information and informed consent form\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Men with an intention to conceive a child during the time of the study\n* Contraindications to Metformin (hypersensitivity to metformin or to one of the excipients)\n* Respiratory:\n\n  * Patient requiring tracheotomy or\n  * Patient requiring non-invasive-ventilation: - more than 12 hours per day; - insufficiently ventilated\n* Creatinine clearance inferior to 50 ml\u002Fmin\n* Cardiac:\n\n  * Left ventricular ejection fraction below 35%\n  * 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\n  * Third-degree or Second degree type II atrioventricular block without a pacemaker or an implantable defibrillator\n  * Sustained ventricular tachycardia\n* Acute disease that may lead to tissue hypoxia","ALL","18 Years","70 Years",{"count":21,"type":22},142,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study team hypothesize that non-diabetic patients with Myotonic dystrophy type I (DM1) will improve their symptoms, especially their motor deficit which is the main feature of the disease, because of the splicing defect correction by metformin.\n\nThe primary objective of the study is to evaluate the efficacy of metformin vs placebo, on the improvement of muscle function in patients with DM1 compared to its placebo.\n\nAs the secondary objectives, the study aims:\n\n* To evaluate the safety of metformin on patient with DM1.\n* To evaluate the efficacy of metformin vs placebo on:\n\n  1. The hand-grip strength;\n  2. The thumb-index pinch strength;\n  3. The locomotor function;\n  4. The respiratory function;\n  5. The cardiac function;\n  6. The quality of life;\n  7. The daily and social activity.",[28,29,30],"Steinert's Disease","Myotonic Dystrophy 1","Metformin",[28,29,30,32],"Muscle function","RECRUITING","2025-11-19",{"date":36,"type":37},"2025-11-24","ACTUAL",{"date":39,"type":37},"2024-11-29",{"date":41,"type":22},"2026-12",{"name":43,"class":44},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":67,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":45},"100063959","myotonic-dystrophy-and-facioscapulohumeral-muscular-dystrophy-registry-100063959","NCT00082108","Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry","National Registry of Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Patients and Family Members","Inclusion Criteria:\n\n* Diagnosed with DM, FSHD, or related diseases or are an unaffected family member of someone diagnosed with one of these diseases",true,{"count":55,"type":22},3000,"OBSERVATIONAL","Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose of this registry is to connect people with DM or FSHD with researchers studying these diseases. The registry will offer individuals with DM and FSHD an opportunity to participate in research that focuses of their diseases. The registry will also help scientists to accomplish research on DM and FSHD and to distribute their findings to patients and care providers.",[59,60,61,62,63,64,65,28,66],"Myotonic Dystrophy","Facioscapulohumeral Muscular Dystrophy","Muscular Dystrophy","Myotonic Dystrophy Type 1","Myotonic Dystrophy Type 2","Congenital Myotonic Dystrophy","PROMM (Proximal Myotonic Myopathy)","Myotonic Muscular Dystrophy",[68,69,70,61,71,59,72,73,74,75],"Registry","FSHD","DM","Facioscapulohumeral Myotonic Dystrophy","DM1","DM2","FSH","MMD","2025-10-10",{"date":78,"type":37},"2025-10-15",{"date":80,"type":4},"2000-09",{"date":82,"type":22},"2028-06",{"name":84,"class":44},"University of Rochester",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":94,"studyType":56,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":45},"100239721","myotonic-dystrophy-family-registry-100239721","NCT02398786","Myotonic Dystrophy Family Registry","MDFR","Inclusion Criteria:\n\n* Diagnosed with congenital, juvenile-onset or adult onset DM1 or DM2 (confirmed by clinical exam or genetic test)\n\nExclusion Criteria:\n\n* Not diagnosed with DM, unaffected family members",{"count":93,"type":22},3500,"5 Years","The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.",[59,64,29,97,98,99,100,101,102,103,65,104,105,106,28,107],"Myotonic Dystrophy 2","Dystrophia Myotonica","Dystrophia Myotonica 1","Dystrophia Myotonica 2","Myotonia Dystrophica","Myotonic Dystrophy, Congenital","Myotonic Myopathy, Proximal","Proximal Myotonic Myopathy","Steinert Disease","Steinert Myotonic Dystrophy","Myotonia Atrophica","2024-11-19",{"date":110,"type":37},"2024-11-21",{"date":112,"type":4},"2013-02",{"date":114,"type":22},"2030-02",{"name":116,"class":44},"Myotonic Dystrophy Foundation"]