[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658882":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":75,"studyPopulation":68,"armGroups":76,"interventions":83,"overallOfficials":88,"centralContacts":92,"locations":98,"responsibleParty":116,"collaborators":68,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":68,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":68,"enrollmentInfo":127,"targetDuration":68,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":140,"whyStopped":68,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Ambros Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":68},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Treatment Emergent Adverse Events (TEAEs), Acute Phase Reaction (APRs) and Treatment Emergent Serious Adverse Events (TESAEs) and Suspected Unexpected Serious Adverse Events (SUSARs) during the Open Label Extension Study.","Endpoints will be summarized descriptively. Descriptive statistics for categorical variables will be frequencies and percentages. Descriptive statistics for continuous variables will be means, standard deviations, medians, minimums, and maximums.","Week 12",[14,18,21,23,26,28,31,34,37,40,43,46,50,52,55,58,61,63,66],{"measure":15,"description":16,"timeFrame":17},"Change in \"average pain\" from baseline","Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain.","Day 10, Weeks 3, 6, and 12",{"measure":19,"description":20,"timeFrame":17},"At least a 30%, 50%, 70%, and 90% reduction of \"average pain\" from baseline","Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain",{"measure":22,"description":16,"timeFrame":17},"Change from baseline in \"pain now\"",{"measure":24,"description":25,"timeFrame":17},"At least a 30%, 50%, 70%, and 90% reduction from baseline in \"pain now\"","Assessed using an 11-point Numerical Scale (NRS) with 0 representing no pain and 10 the worst possible pain",{"measure":27,"description":16,"timeFrame":12},"Change from baseline in \"worst pain\"",{"measure":29,"description":16,"timeFrame":30},"At least a 30%, 50%, 70%, and 90% reduction from baseline of \"worst pain\"","Day 10 and Weeks 3, 6, and 12",{"measure":32,"description":33,"timeFrame":17},"Change from baseline in the CRPS Severity Score (CSS)","Assessed using the CRPS CSS, a 0-16 scale where higher scores denotes greater CRPS symptom severity and lower scores reflect milder symptoms.",{"measure":35,"description":36,"timeFrame":12},"Change from baseline to Week 12 in the CSS self-report (CSS-SR).","Assessed using the CRPS CSS-SR, a 0-13 scale where higher scores denotes greater CRPS symptom severity and lower scores reflect milder symptoms.",{"measure":38,"description":39,"timeFrame":17},"Change from baseline in edema of affected limb","Assessed using the \"edema\" 4-point numerical rating scale where 0 is no edema and 3 is severe edema.",{"measure":41,"description":42,"timeFrame":30},"Change from baseline in temperature (°C) of the affected limb vs contralateral limb.","Assessment of 'temperature' is defined as the difference in temperature, measured in degrees Celsius (°C) using an infrared thermometer, between the affected limb and the contralateral limb.",{"measure":44,"description":45,"timeFrame":30},"Patient Global Impression of Change (PGI-C) in CRPS-related health","Assessed using a categorical scale of: \"very much improved,\" \"much improved,\" \"minimally improved,\" \"no change,\" \"minimally worse,\" \"much worse,\" and \"very much worse,\" which will be mapped to numeric values of 1, 2, 3, 4, 5, 6, or 7 respectively.",{"measure":47,"description":48,"timeFrame":49},"Clinician Global Impression of Change (CGI-C) in CRPS-related health","Assessed using a categorical scale of: \"very much improved,\" \"much improved,\" \"minimally improved,\" \"no change,\" \"minimally worse,\" \"much worse,\" and \"very much worse,\" which correspond to numeric values of 0, 1, 2, 3, 4, 5, 6 and 7 respectively.","Day 10 and Weeks 3, 6, and 12.",{"measure":51,"description":48,"timeFrame":30},"Change from baseline in Patient Global Impression of Severity (PGI-S) in CRPS Severity.",{"measure":53,"description":54,"timeFrame":30},"Change from baseline in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) (a) total pain score, (b) each of 4 domain scores, (c) single items.","Assessed using a response to 22 descriptors rated on an 11-point numerical scale (NRS), capturing both neuropathic and non-neuropathic aspects. These descriptors are grouped into four core domains-Continuous Pain, Intermittent Pain, Neuropathic Pain, and Affective Descriptors-with domain scores calculated as the mean of items within each domain. The overall pain score is derived from the average of the 22 items. The complete scale runs from 0 to 10, where a higher score represents greater pain severity",{"measure":56,"description":57,"timeFrame":30},"Moderate (at least 30%) and substantial (at least 50%) improvement from baseline in SF-MPQ-2 (a) total pain score, and (b) each of 4 domain scores.","Assessed using a response to 22 descriptors rated on an 11-point numerical scale (NRS), capturing both neuropathic and non-neuropathic aspects. These descriptors are grouped into four core domains-Continuous Pain, Intermittent Pain, Neuropathic Pain, and Affective Descriptors-with domain scores calculated as the mean of items within each domain. The overall pain score is derived from the average of the 22 items. The complete scale runs from 0 to 10, where a higher score represents greater pain severity.",{"measure":59,"description":60,"timeFrame":30},"Change from baseline in the 36-item Short Form 36 Item Health Survey [SF-36] (a) 8 domain scores and (b) 2 component summary scores.","Assessment focuses on changes across eight domains: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy\u002FFatigue, Emotional Well-being, and Social Functioning. Two summary scores-Physical Component Summary and Mental Component Summary-are derived. All domain scores are standardized to a 0-100 scale, with higher scores reflecting better health status",{"measure":62,"description":60,"timeFrame":30},"Moderate (at least 30%) and substantial (at least 50%) improvement from baseline in the SF-36 (a) 8 domain scores and (b) 2 component summary scores.",{"measure":64,"description":65,"timeFrame":30},"Change from baseline in the Daily Sleep Interference Scale (DSIS) assessment on an 11-point NRS.","Assessed using the 7-day average score on the 11-point Numerical Rating Scale (NRS), where 0 represents did not interfere with sleep and 10 represents completely interfered with sleep - unable to sleep due to CRPS pain",{"measure":67,"description":65,"timeFrame":30},"Moderate (at least 30%) and substantial (at least 50%) improvement from baseline in the DSIS assessment.",null,{"allocation":70,"interventionModel":71,"interventionModelDescription":68,"primaryPurpose":72,"observationalModel":68,"timePerspective":68,"maskingInfo":73},"NA","SINGLE_GROUP","TREATMENT",{"masking":74,"maskingDescription":68,"whoMasked":68},"NONE","This is a multicenter, open-label extension study to assess the safety, tolerability, and efficacy of IV neridronate 400 mg in eligible participants who have completed the Phase 3 AMBTX-01-301 Randomized Clinical Trial.\n\nThe total planned trial duration for each participant will be approximately up to 24 weeks and will include:\n\n* Screening period of up to 12 weeks\n* Treatment period on Days 1, 4, 7, and 10\n* Post-treatment follow-up through Week 12",[77],{"label":78,"type":79,"description":80,"interventionNames":81},"Neridronate","EXPERIMENTAL","400 mg AMBTX-01 infusion",[82],"Drug: Neridronate",[84],{"type":85,"name":78,"description":86,"armGroupLabels":87,"otherNames":68},"DRUG","100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.",[78],[89],{"name":90,"affiliation":5,"role":91},"Gail Cawkwell, MD, PhD","STUDY_DIRECTOR",[93],{"name":94,"role":95,"phone":96,"phoneExt":68,"email":97},"Medical Affairs Ambros Therapeutics","CONTACT","949-508-0173","Medinfo@ambrostx.com",[99],{"facility":100,"status":68,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Ambros Clinical Study Site","Phoenix","Arizona","85032","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-112.07404,33.44838,{"lat":110,"lon":109},[113],{"name":68,"role":95,"phone":114,"phoneExt":68,"email":115},"+1 602-288-4673","shana.harshell@hriaz.com",{"type":117,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR","100658882","phase-3-phase-3-open-label-extension-study-of-ambtx-01-neridronate-for-complex-regional-pain-syndrome-type-1-100658882",false,"NCT07857733","Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1","An Open-Label, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous AMBTX-01 (Neridronate) for the Treatment of Complex Regional Pain Syndrome Type 1","Inclusion Criteria:\n\n1. Participants must have completed the Week 12 visit of the neridronate AMBTX-01-301 Randomized Clinical Trial (RCT).\n2. Both the Investigator and participant must agree that the participant is reasonably likely to benefit from neridronate therapy without undue risk based on information about benefits\u002Frisks in the IB.\n3. The Investigator must characterize the participants CRPS-1 as a serious condition based on the presence of persistent moderate-to-severe pain or\u002Fand persistent moderate-to-severe CRPS-1 signs or\u002Fand symptoms other than pain.\n4. Participants must be capable of understanding the study requirements and willing to provide informed consent prior to any study-related procedures.\n5. Participants must be willing and able to comply with the scheduled treatment plan including 4 infusion visits and safety-related assessments.\n6. Participants must have adequate venous access to enable blood sampling and 4 IV infusions.\n7. Women of childbearing potential must:\n\n   1. Be nonpregnant as determined by a negative highly sensitive urine pregnancy test on every visit before neridronate administration.\n   2. Be nonlactating.\n   3. Agree to use a highly effective method of contraception from at least 28 days prior to treatment for oral contraception (or at least 1 week longer than specified by the manufacturer for other contraceptives) and for at least 6 months following last neridronate administration.\n\nException: Women exclusively engaging in same sex sexual activities are not required to meet this criterion.\n\nExclusion Criteria:\n\n1. Individuals who did not participate in AMBTX-01-301 RCT, or those participants from AMBTX-01-301 RCT who discontinued investigational product and\u002For were withdrawn from the trial.\n2. Evidence of severely impaired renal function .\n3. Prior or planned renal transplant.\n4. The use of any of the following treatments within the timeframe specified from initiation of treatment with neridronate and through the study:\n\n   1. Within the last 12 months - IV immunoglobulin, any IV bisphosphonates (excluding investigational product as part of AMBTX-01-301 RCT prior to open-label treatment);\n   2. Within the last 6 months: Any oral bisphosphonate, denosumab (Prolia®) or receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors (e.g., denosumab biosimilar compounds), Calcitonin, ketamine, Radiation therapy to the head or neck;\n   3. Within the last 3 months: Cinacalcet, Monoclonal antibody peptides against calcitonin gene-related peptide (CGRP), spinal cord stimulation, radiofrequency ablation, peripheral nerve stimulation and other procedural forms of neuromodulation\n   4. Within the last 1 month - Any systemic corticosteroid (intranasal, inhaled, or topical corticosteroids are acceptable)\n   5. Within 2 weeks - Lidocaine infusion, somatic or sympathetic nerve blocks, acupuncture, electromagnetic field treatment, scrambler therapy, dorsal root ganglia (DRG) block, initiation or implementation of radiofrequency ablation or other sympathectomy procedures\n5. Hypocalcemia, or high risk for hypocalcemia\n6. Vitamin D deficiency\n7. Serum potassium or magnesium outside of the laboratory's reference range at Screening\n8. Elevated liver-related lab tests or evidence of significant liver disease\n9. Significant dental findings.\n10. Eye inflammation\n11. Clinically unstable cardiac disease","ALL","18 Years",{"count":128,"type":129},135,"ESTIMATED","INTERVENTIONAL",[132],"PHASE3","A Phase 3 open-label extension study of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1",[135],"Complex Regional Pain Syndrome Type I",[137,138,139],"CRPS-1","Pain","edema","NOT_YET_RECRUITING","2026-10-12",{"date":143,"type":144},"2026-10-14","ACTUAL",{"date":146,"type":129},"2026-10-15",{"date":148,"type":129},"2029-02-15",{"name":5,"class":6},1]