[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-system-atrophy-parkinson-variant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-system-atrophy-parkinson-variant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100656509","phase-3-a-trial-of-ono-2808-in-participants-with-the-parkinsonian-subtype-of-multiple-system-atrophy-msa-p-100656509",false,"NCT07825402","A Trial of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)","A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)","Key Inclusion Criteria:\n\n* Participants with a diagnosis of clinically established or clinically probable MSA-P according to the 2022 Movement Disorder Society (MDS) criteria for MSA diagnosis.\n* Participants in the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA-P:\n\n  * Parkinsonism\n  * Orthostatic hypotension\n  * Urinary dysautonomia\n* Participants with an anticipated survival of at least 3 years in the opinion of the Investigator.\n* Participants who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. Use of assistive devices (eg, walker or cane) is allowed.\n* Ability to swallow oral medication and willingness to adhere to the study drug regimen.\n* Normal range of laboratory values at screening and baseline, especially liver function tests.\n* Participants receiving treatment (including chronic medications, and herbal or dietary supplements) for symptoms associated with MSA must be on a stable dosage for at least 60 days prior to randomization based on the judgment of the Investigator. Participants must not initiate new treatment within 60 days prior to randomization.\n\nKey Exclusion Criteria:\n\n* Participants with the cerebellar subtype of MSA according to the 2022 MDS criteria for MSA diagnosis.\n* Female participants who are pregnant, planning to become pregnant during the study, or breastfeeding.\n* Participants with a clinically significant or unstable medical or surgical condition other than MSA-P that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (eg, pulmonary, cardiovascular \\[including bradyarrhythmia\\], macular edema, and significant renal or hepatic dysfunction).\n* Neurological diseases\u002Fdisorders other than MSA-P, such as Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or postencephalitic parkinsonism.\n* Any abnormalities, other than MSA, found on the centrally read brain MRI that, in the opinion of the Investigator, may constitute a confounder for the study or preclude safe participation.\n* Participants with documented liver diseases, cirrhosis, prior drug-induced liver injury (DILI), or ascites or symptoms and signs of encephalopathy due to hepatic dysfunction.\n\nOther protocol-defined inclusion and exclusion criteria apply.","ALL","30 Years","80 Years",{"count":20,"type":21},486,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P.\n\nParticipants will:\n\n* Take ONO-2808 or placebo orally for up to 48 weeks\n* Make visits to the clinic for checkups and tests\n* Answer questions about their health throughout the trial.",[27],"Multiple System Atrophy, Parkinson Variant",[29,30,31,32,33,34,35],"MSA-P","Parkinson's","Parkinsonian Subtype of","Parkinsonism","MSA","Multiple System Atrophy","Movement Disorder","NOT_YET_RECRUITING","2026-09-13",{"date":39,"type":40},"2026-09-17","ACTUAL",{"date":42,"type":21},"2027-01",{"date":44,"type":21},"2029-10",{"name":46,"class":47},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100580541","transcutaneous-spinal-cord-stimulation-home-study-100580541","NCT06838637","Transcutaneous Spinal Cord Stimulation Home Study","The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions","INCLUSION CRITERIA\n\n* A participant must meet all of the following criteria in order to be eligible for inclusion:\n\n  1. Resident of British Columbia, Canada with active provincial medical services plan\n  2. Male or female, 19-70 years of age The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in individuals with severe autonomic dysfunctions (H23-00192) Protocol Version 1.0, December 8, 2023 Page 6 of 23\n  3. Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (MSA) of the parkinsonian type.\n  4. \\>1-year post injury or diagnosis, at least 6 months from any spinal surgery.\n  5. American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.\n  6. Willing and able to comply with all clinic visits and study-related procedures.\n  7. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).\n  8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.\n  9. Stable management of spinal cord related clinical issues (i.e., spasticity management).\n  10. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:\n\n      10.1. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.\n\n      10.2. Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.\n  11. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.\n  12. Must provide informed consent.\n\nEXCLUSION CRITERIA\n\n* A participant who meets any of the following criteria will be ineligible to participate:\n\n  1. Ventilator dependent.\n  2. Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.\n  3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.\n  4. Intrathecal baclofen pump.\n  5. Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive renal stones.\n  6. Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \\[tricyclics\\], debilitating muscle pain, pressure sores, or unstable diabetes.\n  7. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.\n  8. Takes more than 40mg of Baclofen per day.\n  9. Severe anemia (Hgb\\\u003C8 g\u002Fdl or Hgb,80 g\u002FL) or hypovolemia as measured by hematocrit via blood test in the last six months.\n  10. Participant is a member of the investigational team or his\u002Fher immediate family.\n  11. Participant has undergone electrode implantation surgery.","19 Years","70 Years",{"count":58,"type":21},6,[60],"NA","The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are:\n\n* To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre\n* To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction\n\nParticipation will last approximately 10 weeks (excluding screening period) and involves\n\n* Attending the study center to collect baseline evaluations and to plan where electrodes will be placed\n* A 2 week treatment period at the centre with 3 visits per week\n* A 6 week home based therapy period involving 1 hour treatments twice a day\n* Attending the study center to collect post-treatment evaluations",[63,27],"Spinal Cord Injuries",[65,66,67,68,69],"Transcutaneous Spinal Cord Stimulation","SCONE","Orthostatic Hypotension","Bowel Dysfunction","Autonomic Dysfunction","RECRUITING","2025-02-17",{"date":73,"type":40},"2025-02-20",{"date":75,"type":40},"2024-02-15",{"date":77,"type":21},"2026-04-01",{"name":79,"class":80},"Michael Berger","OTHER",1]