[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fshd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fshd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,69,92,117,146],{"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":14,"conditions":26,"keywords":44,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100595880","phase-3-a-study-to-evaluate-del-brax-also-referred-to-as-aoc-1020-in-participants-with-fshd-100595880",false,"NCT07038200","A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD","A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)","FORTITUDE-3","Inclusion Criteria:\n\n* Clinical and genetic diagnosis of FSHD1 or FSHD2\n* Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening\n* Adequate muscle strength based on QMT composite score\n\nExclusion Criteria:\n\n* Breastfeeding, pregnancy, or intent to become pregnant during the study\n* Unwilling or unable to comply with contraceptive requirements\n* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study\n* Blood Pressure \\> 140\u002F90 mmHg at Screening\n* Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer\n* Treatment with an oligonucleotide within 9 months of Screening","ALL","16 Years","70 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Facioscapulohumeral Muscular Dystrophy","FSHD","FSHD - Facioscapulohumeral Muscular Dystrophy","FSHD1","FSHD2","Fascioscapulohumeral Muscular Dystrophy","Fascioscapulohumeral Muscular Dystrophy Type 1","Fascioscapulohumeral Muscular Dystrophy Type 2","Facioscapulohumeral Muscular Dystrophy 1","Facioscapulohumeral Dystrophy","Facio-Scapulo-Humeral Dystrophy","Facioscapulohumeral Muscular Dystrophy 2","Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)","FSH Muscular Dystrophy","Landouzy Dejerine Dystrophy","Landouzy-Dejerine Muscular Dystrophy","Landouzy-Dejerine Syndrome",[45,46,47,48,49,50,51,52,15,53,54,55],"Avidity","Avidity Biosciences","del-brax","del brax","delbrax","AOC1020","AOC 1020","delpacibart braxlosiran","FORTITUDE Phase 3","FORTITUDE","FORTITUDE 3","RECRUITING","2026-05-27",{"date":59,"type":60},"2026-05-29","ACTUAL",{"date":62,"type":60},"2025-06-10",{"date":64,"type":22},"2028-07",{"name":66,"class":67},"Avidity Biosciences, Inc.","INDUSTRY",46,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100411312","motor-outcomes-to-validate-evaluations-in-fshd-move-fshd-100411312","NCT04635891","Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)","MOVE FSHD","Inclusion Criteria:\n\n* Genetically confirmed FSHD (types 1 or 2) or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring.\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent.\n* Any other medical condition which in the opinion of the investigator would interfere with study participation.",{"count":77,"type":22},450,"OBSERVATIONAL","The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD.\n\nMotor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and reachable workspace, as well as optional muscle biopsy and wearable device (US participants only).",[28],"2026-05-04",{"date":83,"type":60},"2026-05-07",{"date":85,"type":60},"2020-12-15",{"date":87,"type":22},"2028-01",{"name":89,"class":90},"University of Kansas Medical Center","OTHER",21,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100626399","phase-2-phase-2-study-evaluating-apitegromab-for-the-treatment-of-fshd-100626399","NCT07435129","Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study Evaluating the Efficacy and Safety of Apitegromab in Participants With Facioscapulohumeral Muscular Dystrophy (FORGE)","Inclusion Criteria:\n\n1. Male or female participants, 18 to 60 years of age at the time of informed consent.\n2. Genetic diagnosis of FSHD Type 1 or FSHD Type 2, confirmed with the appropriate documentation from an accredited laboratory\n3. Clinical severity score of 1.5 to 3.0 (Ricci score; range 0 to 5), inclusive, at screening\n4. Baseline 10-meter walk\u002Frun test time ≤5 seconds\n\nExclusion Criteria:\n\n1. Prior history of a hypersensitivity reaction to a mAb or recombinant protein bearing an Fc domain (eg, a soluble receptor-Fc fusion protein), apitegromab, or excipients of apitegromab\n2. Treatment with other investigational drugs in a clinical trial within 3 months or 5 half-lives, whichever is longer, before screening\n3. Previous treatment with apitegromab, or with other anti-myostatin therapies, including activin receptor antagonists\n4. Current or prior use of anabolic steroids, growth hormones, glucagon-like peptide-1 receptor agonist or other substances with known effects on muscle.\n5. Use of therapies with potentially significant muscle effects (eg, androgens, insulin-like growth factor, growth hormone, systemic beta-agonist, botulinum toxin, or muscle relaxants or muscle-enhancing supplements) or potentially significant neuromuscular effects (eg, acetylcholinesterase inhibitors) within 60 days before screening\n6. Use of systemic or corticosteroids within 60 days prior to screening. Inhaled or topical steroids are allowed.\n7. Pregnant or breastfeeding.\n8. Contraindications for MRI that may include, but are not limited to, certain implanted electronic devices, cochlear implants, metallic foreign bodies, vascular clips, and metallic implants; or claustrophobia, contrast agent allergies, inability to lie still, or external medical devices that may not be removed.\n\nHistory of alcoholism, or illicit drug use (drugs that are illegal and have not been prescribed).\n\nTaking medications that impede coagulation or platelet aggregation or has a history or active coagulopathy disorder.\n\nAny acute or comorbid condition interfering with the well-being of the participant within 7 days prior to screening, including active systemic infection, the need for acute treatment, or inpatient observation due to any reason","18 Years","60 Years",{"count":102,"type":22},60,[104],"PHASE2","A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD",[27,28],"NOT_YET_RECRUITING","2026-02-24",{"date":110,"type":60},"2026-02-27",{"date":112,"type":22},"2026-08",{"date":114,"type":22},"2028-12",{"name":116,"class":67},"Scholar Rock, Inc.",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":78,"phases":4,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100624400","betterlife-fshd-a-patient-driven-health-and-research-platform-100624400","NCT07409142","BetterLife FSHD: A Patient-driven Health and Research Platform","Inclusion Criteria:\n\n* Individuals with a clinical or genetic diagnosis of FSHD, or individuals with a family history of FSHD who are showing symptoms\n* Age 1 year or older\n* Residing in the United States or its territories\n* If age 18 or older, individual must be able and willing to provide consent\n* If under age 18, individual must be able and willing to provide assent, when applicable, and have a parent or legal guardian register and provide consent\n\nExclusion Criteria:\n\n* Individuals residing outside the United States or its territories\n* Unable or unwilling to provide consent, or assent, when applicable","1 Year",{"count":125,"type":22},5000,"100 Years","BetterLife FSHD is a registry platform built to support people living with FSHD. It connects patients with personalized resources, tools, and research opportunities that match their health experiences and needs. At the same time, BetterLife collects secure health and experience data from patients to support research. This data is shared with researchers to help better understand FSHD and work toward improved care, treatments, and outcomes for the community.\n\nLearn more and enroll at: www.BetterLifeFSHD.org",[129,40,29,30,28,31,27,35,38,130,131],"FSH","Facioscapulohumeral Muscular Dystrophy (FSHD)","Muscular Dystrophy, Facioscapulohumeral",[28,133,40,30,31,134,135],"Registry","Facioscapulohumeral dystrophy","facioscapulohumeral muscular dystrophy","2026-02-19",{"date":138,"type":60},"2026-02-20",{"date":140,"type":60},"2024-08-02",{"date":142,"type":22},"2060-01",{"name":144,"class":90},"FSHD Society",1,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100570807","testing-a-tailored-home-exercise-program-to-reduce-pain-and-fatigue-in-patients-with-fshd-100570807","NCT06712043","Testing a Tailored Home Exercise Program to Reduce Pain and Fatigue in Patients with FSHD.","Testing a Tailored Home Exercise Program to Gain Insight Into Performance Fatigability and Reduce Pain and Fatigue in Patients with FSHD: the GRIP on FSHD Study","GRIPonFSHD","Inclusion Criteria:\n\n* Age \\>18 years\n* Verified diagnosis of FSHD type 1, based on the clinical criteria established by Padberg et al. (1991) (22).\n* Category A or B of the four clinical categories according to the Comprehensive Clinical Evaluation Form (23), these patients have the most peculiar signs of the disease\n* A CIS-fatigue score of ≥ 35\n* Owning of and being able to use a smartphone\n* Preserved ability to ambulate at the time of the selection\n* No pulmonary or cardiological involvement, that could interfere with physical training.\n* Absence of central or peripheral nervous system involvement as from neurological history and physical assessment\n* Absence of limb contractures and tendon retractions\n\nExclusion Criteria:\n\n* Use of beta-blocker medication\n* Presence of additional diseases likely to interfere with the measurements\n* Psychological-psychiatric disorders\n* A musculoskeletal injury that impairs exercising\n* Scoliosis that impairs training\n* Recent adjustment of any medications or medications that may impact fatigue or taking stimulants for fatigue (e.g., Modafinil, amantadine)\n* Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study\n* Pregnant women\n* Patient incapable of understanding the purpose and conditions of the study, incapable of giving consent or using the app\n* Patient deprived of liberty or patient under guardianship",{"count":155,"type":22},50,[157],"NA","The goal of this intervention study is to determine the effect of a tailored exercise program (with aerobic, strength and balance training) in patients with FSHD.\n\nThe main aim is to determine the effect of the exercise program on pain and fatigue.\n\nParticipants will follow a 16 week training program with tailored exercises. The exercises will be prescribed via the app 'Physitrack'. After 16 weeks, the effect on pain, fatigue, fatigability, aerobic capacity, balance, physical function, sleep and the ability to participate in social activities will be determined.",[28],[161,162,163,164,165,166,167,168,169],"Personalized exercise","Rehabilitation","Aerobic exercise","Strength training","Balance training","Fatigue","Pain","Fatigability","Smartphone application","2024-11-26",{"date":172,"type":60},"2024-12-02",{"date":174,"type":22},"2025-02",{"date":176,"type":22},"2025-07",{"name":178,"class":90},"Radboud University Medical Center"]