[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655493":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":44,"armGroups":45,"interventions":35,"overallOfficials":52,"centralContacts":57,"locations":63,"responsibleParty":81,"collaborators":35,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":35,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":35,"enrollmentInfo":92,"targetDuration":95,"studyType":96,"phases":35,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":66,"whyStopped":35,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Ambros Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":36},[9,13,16,20,23,26,29,32],{"measure":10,"description":11,"timeFrame":12},"Change from baseline to each registry assessment of average pain in the past 24 hours.","Average pain (24-hour recall) reported on an 11-point numeric rating scale. This is recorded every 90 days from entry.","Every 3 months from enrollment until up to 2 years after entry.",{"measure":14,"description":15,"timeFrame":12},"Time to loss of benefit where benefit is 50% reduction in average pain intensity from baseline to Week 12 of the CRPS-RISE trial.","Each patient reported registry assessment of average pain in the past 24 hours will use an 11 point numeric rating scale. The analysis will be limited to participants who experienced benefit. Data will be summarized as Kaplan-Meier estimates.",{"measure":17,"description":18,"timeFrame":19},"Change from baseline to each registry assessment in CRPS Severity Score Self-Report (CSS-SR) total score and individual items.","The CSS-SR is designed as a patient self-report questionnaire to assess the severity of CRPS signs and symptoms using plain language to assess 13 concepts.","Every 3 months from entry to up to 24 months of participation.",{"measure":21,"description":22,"timeFrame":12},"Change from baseline to each registry assessment in Patient Global Impression of Severity (PGI-S).","The 6-point PGI-S is an overall assessment of the participant's perception of the severity of their CRPS condition at the time of the assessment. Participants will respond to the question \"How would you rate the symptoms of your CPRS at this time.\" Possible responses are scored from 0 to 5 representing none, minimal, mild, moderate, severe, very severe.",{"measure":24,"description":25,"timeFrame":12},"Change from baseline to each registry assessment in each of the Short Form 12 Health Survey (SF-12, Acute Version 2) domains, Physical Component Score (PCS), Mental Component Score (MCS), and individual items.","The SF-12 is a widely used measure of general health status used in observational studies across a broad range of disease areas. It is a shortened version of the SF-36 V2.0 and yields 8 domain scores and a Physical Component Summary and Mental Component Summary. Each domain score is calculated by transforming raw responses to a 0-100 scale, where higher scores indicate better health status.",{"measure":27,"description":28,"timeFrame":12},"Change from baseline to each registry assessment in Daily Sleep Interference Scale (DSIS) in the past 24 hours on an 11-point numeric rating scale.","The DSIS is a single-item scale that assesses \"how much did your pain interfere with your sleep during the past 24 hours?\" (0 = did not interfere; 10 = completely interfered",{"measure":30,"description":31,"timeFrame":12},"CRPS-1 Related Clinical Events during the 3 months preceding each registry assessment.","The CRPS-1 Treatment Checklist was developed for this registry to assess commonly used pharmacologic treatments (e.g., opioids, neuropathic pain agents, ketamine, NSAIDs, bisphosphonates, corticosteroids, and topicals),interventional procedures (e.g., spinal cord or dorsal root ganglion stimulation, peripheral nerve stimulation, stellate\u002Flumbar sympathetic blocks, sympathetic ablation\u002Fsympathectomy, intrathecal pump implant, and Bier block), and non-invasive rehabilitation therapies (e.g., physical therapy, occupational therapy, mirror visual feedback, psychological therapies, scrambler therapies or acupuncture). Participants select all CRPS-related treatments used in the past 3 months. The checklist will also record participation in the open-label clinical trial and is intended for descriptive evaluation of long-term CRPS-1 treatments with a focus on resource intensive events. The outcome domain assesses the long-term effectiveness of neridronate through patient reports.",{"measure":33,"description":34,"timeFrame":12},"Disability Status","During the 3 months preceding each registry assessment the participant reported applying for or being on short-term disability, long-term disability, or workers compensation. As a binary endpoint, it will be summarized as frequencies and percentages. The domain assesses the long-term effectiveness of neridronate through patient reports of short-term disability, long-term disability, and workers compensation.",null,[37],{"measure":38,"description":39,"timeFrame":12},"Healthcare Use and Costs (Provisional)","The potential for inclusion of linked health care claims and electronic health record data will be enabled by having participants consent to tokenizing their identifying information.",{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":41,"timePerspective":42,"maskingInfo":35},"CASE_ONLY","PROSPECTIVE","The primary objective of the registry is to evaluate the long-term effectiveness of IV neridronate across three outcome domains in participants who qualified in CRPS-RISE with early, warm CRPS-1 and a positive triple phase bone scan, following prior treatment with four infusions of neridronate 100 mg IV over approximately a 10-day period. The three outcome domains include, patient report of health status, CRPS-1 related clinical events, and disability status.\n\nNo neridronate treatment will be given as part of the registry and limited safety information will be collected. Participants will have received neridronate either through CRPS-RISE and\u002For through the Open Label Extension.","The registry target population for provisional enrollment includes all participants in CRPS-RISE, the parent trial of the Registry. After the completion of the last participant's last visit in CRPS-RISE and the unblinding of the trial, the Enrolled Study Cohort will be participants confirmed to have completed a four-infusion course of neridronate. The Enrolled Study Cohort will also include participants in the Open Label Extension study.",[46,49],{"label":47,"type":35,"description":48,"interventionNames":35},"Provisionally Enrolled Study Cohort","Participants provisionally enrolled in the registry. (Note: Participants provisionally enrolled who do not meet this neridronate-exposure criterion will not continue registry follow-up.)",{"label":50,"type":35,"description":51,"interventionNames":35},"Enrolled Study Cohort","Participants who have consented to participate and meet all inclusion criteria including confirmation of completing four infusions of neridronate.",[53],{"name":54,"affiliation":55,"role":56},"Joel Castellanos, MD","UCSD","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":35,"email":62},"CRPS-RiseRegistry","CONTACT","877-834-5183","CRPS-RiseRegistry@iqvia.com",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"CRPS-RISERegistry","RECRUITING","Durham","North Carolina","27703","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-78.89862,35.99403,{"lat":76,"lon":75},[79],{"name":80,"role":60,"phone":61,"phoneExt":35,"email":62},"CRPS-RiseRegistry CRPS-RiseRegistry",{"type":82,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100655493","crps-rise-outcomes-registry-100655493",false,"NCT07811362","CRPS-RISE Outcomes Registry","A Prospective Longitudinal Outcomes Registry of Complex Regional Pain Syndrome Type 1 (CRPS-1) in Participants Treated With Neridronate in the CRPS-RISE Trial and\u002For Open-Label Extension (OLE)","Inclusion Criteria:\n\n* Participants from CRPS-RISE\n\n  1. Completion of four infusions of IP (neridronate 100 mg over a \\~ 10-day period \\[or the renally modified dosing, as applicable\\] or placebo) in CRPS-RISE .\n  2. Completed CRPS-RISE with a final trial visit at Week 6 (Visit 8) or later.\n\n     Participants who meet both criteria will be provisionally enrolled pending post-trial unblinding and be included in the Provisionally Enrolled Study Cohort.\n\n     After CRPS-RISE last patient last visit unblinding, only participants who meet the following neridronate exposure criterion #3 will continue in registry follow-up and be included in the Enrolled Study Cohort:\n  3. Completion of 4-infusions of neridronate 100 mg over approximately a 10-day period in CRPS-RISE.\n* Participants from the Open Label Extension (OLE)\n\n  1. Completion of 4 infusions of neridronate 100 mg over approximately a 10-day period (or the renally modified dosing, as applicable) in the OLE.\n  2. Completed OLE with a final trial visit at Week 6 (Visit 8) or later.\n\nExclusion Criteria:\n\nThere are no exclusion criteria.","ALL","18 Years",{"count":93,"type":94},270,"ESTIMATED","12 Months","OBSERVATIONAL","The goal of this observational study is to learn about how well neridronate keeps working in the months after treatment. For 12 or up to 24 months while the registry is open participants will answer online survey questions about their CRPS pain, medication use or procedures done and how CRPS affects what they are able to do.",[99],"Complex Regional Pain Syndrome I (CRPS I)",[101,102,103,104,105,106],"CRPS 1","Reflex Sympathetic Dystrophy","RDS","CRPS","CRPS Type 1","Complex Regional Pain Syndrome Type 1","2026-09-28",{"date":109,"type":110},"2026-09-29","ACTUAL",{"date":112,"type":94},"2026-09-17",{"date":114,"type":94},"2029-04-16",{"name":5,"class":6},1]