[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myotonic-dystrophy-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myotonic-dystrophy-2":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100649177","an-ambispective-natural-history-study-in-myotonic-dystrophy-patients-linking-retrospective-data-captured-from-the-dm-scope-registry-with-a-prospective-24-month-follow-up-period-100649177",false,"NCT07732439","An Ambispective Natural History Study in Myotonic Dystrophy Patients Linking Retrospective Data Captured From the DM-Scope Registry With a Prospective 24-month Follow-up Period","An Ambispective 24-Month Longitudinal Natural History Study in Myotonic Dystrophy Patients Using DM-Scope Registry (TRACK-DM Study)","Track-DM","Inclusion Criteria:\n\n* Enrolled in DM-scope registry genetically diagnosed with DM1 or DM2.\n* Affiliation or beneficiary of a social security system or of such a regime.\n* Ability to comprehend and willingness to sign an informed consent (ICF).\n* Male or non-pregnant female ≥18 years of age at screening.\n* Body Mass Index (BMI) of 18.5 kg\u002Fm2 to 30 kg\u002Fm2, and weight ≥45 kg.\n* Medical history data covering up to 18 months prior to enrollment.\n* Clinical sign of myotonia\n* DM1 patients only - Muscular impairment rating scale (MIRS) score of 2, 3 or 4.\n* Be able to walk independently 10 meters (cane, walker, orthoses allowed).\n\nExclusion Criteria:\n\n* No informed consent.\n* Pregnant or lactating women.\n* Subjects benefiting from laws aimed at protecting vulnerable adults: subjects being deprived of liberty by judicial or administrative decision, subjects under guardianship \u002Fcuratorship.\n* Any medical condition or serious medical illness which in the opinion of the Investigator, precludes the participant's participation in the study or the participant is unlikely to comply with the protocol-defined procedures and therefore is unlikely to complete the study.\n* Medical conditions that could affect hand functioning including (but not limited to) rheumatoid arthritis, Dupuytren's contracture, hand deformity, severe arthritis or any other medical condition (other than DM1\u002FDM2) that would significantly impact ambulation.\n* Patients with no documented record of myotonia assessment in the clinical records of the DM-scope database or myotonia absence at last visit prior to study enrolment.\n* Not able to perform study specific performance tests and evaluations e.g. hand grip dynamometry, 10mWT, etc. (in the opinion of the investigator).\n* Treatment with mexiletine within 18 months prior to baseline (Day 1).","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","24 Months","OBSERVATIONAL","This natural history observational study is being conducted to follow patients with DM1 or DM2 over a 2 year period to study the presence of myotonia, how it's perceived and its impact on patients quality of life. This study will be conducted at 6 study sites located in France.100 Patients will be recruited from the DM Scope Registry only. The study involves two parts. Part 1 will look back up to 18 months of past medical history that is already available from the DM Scope Registry. Part 2 will follow the same patients for 24 months, with study visits at Day 1 (Baseline), 12 months and 24 months. The goal is to better understand how myotonia symptoms and complications such as heart and other systemic problems develop and change over time. A smaller, sub-study will take place at one site, using new exploratory methods in about 40 patients with DM1 who are also part of the Track DM Study.",[26,27],"Myotonic Dystrophy 1","Myotonic Dystrophy 2",[29,30,31,32,33,34,35,36],"Ambispective","Retrospective","Prospective","Natural History","DM-Scope Registry","Observational","DM1","DM2","NOT_YET_RECRUITING","2026-07-23",{"date":40,"type":41},"2026-07-28","ACTUAL",{"date":43,"type":21},"2026-08-03",{"date":45,"type":21},"2029-09",{"name":47,"class":48},"Lupin Ltd.","INDUSTRY",6,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":36,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100571183","investigating-exercise-in-myotonic-dystrophy-type-2-dm2-100571183","NCT06716931","Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)","Investigating Benefits of A Physical Therapist (PT)-Guided Exercise Program in Myotonic Dystrophy Type 2 (DM2)","Inclusion Criteria:\n\n* Patients with genetically confirmed myotonic dystrophy 2 (DM2) who are ≥18 and ≤ 70 years old.\n* Patients are ambulatory without need of any assistance or device.\n* Patients have a normal ECG within the 3 months prior to Screening visit (of note, patients with DM2 are recommended to have routine ECG as part of patient care. So, this ECG will be done as part of patient care).\n* Body mass index (BMI) ≥20 and ≤30.\n\nExclusion Criteria:\n\n* Subjects younger than 18 years old or older than 70 years old.\n* Inability or unwillingness of the subject to give written informed consent.\n* Subjects with pacemaker.\n* Blood pressure \\\u003C90\u002F50 mmHg or \\>160 mmHg\u002F90 mmHg at Screening visit\n* Resting heart rate of \\\u003C60 or \\>100 beats\u002Fminute at Screening visit.\n* Any fall within the last six months.\n* Any history of syncopal episodes or family history of sudden death.\n* Patients who are pregnant or plan to become pregnant. A urine pregnancy test will be performed at visit 1 and 3 for women of childbearing age. If positive or if subject is planning to become pregnant, subject will be not eligible for the study.","70 Years",{"count":59,"type":21},24,"INTERVENTIONAL",[62],"NA","An exercise regimen (PRIME: Proximal Resistance In-House Movement Exercise) has been designed for patients with myotonic dystrophy type 2 (DM2). The hypothesis is that this patient-friendly physical therapist (PT)-guided exercise program associates with improved functional capacity and muscle composition in DM2 in this two-period two-sequence cross-over study. Thus, participant will be randomized to one of the three possible groups. Participants in GROUP A will perform exercise routine virtually under the direct supervision of a physical therapist once a week and another session on their own for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP B will perform exercise routine virtually under the direct supervision of a physical therapist twice a week for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP C will perform exercise routine on their own during the first 3 months, then they will perform exercise routine virtually under the direct supervision of a physical therapist. Each group will include around 8 participants. Duration of the study is 6 months. In addition to exercise sessions, participants will have evaluation of their strength, motor function and muscle composition at three time points: initiation, 3 months and completion of the study at 6 months. Muscle composition will be assessed by electrical impedance myography which is a portable, non-invasive, painless and non-radiation tool that applies a weak high multifrequency electrical current to the examined muscle and allows to obtain information about its composition.",[27],[66,67,68,69],"exercise","physical therapist","myotonic dystrophy type 2","electrical impedance myography","RECRUITING","2026-04-10",{"date":73,"type":41},"2026-04-15",{"date":75,"type":41},"2025-03-04",{"date":77,"type":21},"2028-03-01",{"name":79,"class":80},"Massachusetts General Hospital","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":91,"studyType":23,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":81},"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":90,"type":21},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.",[94,95,26,27,96,97,98,99,100,101,102,103,104,105,106,107],"Myotonic Dystrophy","Congenital Myotonic Dystrophy","Dystrophia Myotonica","Dystrophia Myotonica 1","Dystrophia Myotonica 2","Myotonia Dystrophica","Myotonic Dystrophy, Congenital","Myotonic Myopathy, Proximal","PROMM (Proximal Myotonic Myopathy)","Proximal Myotonic Myopathy","Steinert Disease","Steinert Myotonic Dystrophy","Steinert's Disease","Myotonia Atrophica","2024-11-19",{"date":110,"type":41},"2024-11-21",{"date":112,"type":4},"2013-02",{"date":114,"type":21},"2030-02",{"name":116,"class":80},"Myotonic Dystrophy Foundation"]