[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Milestone Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100571113","phase-3-revera-301-etripamil-in-atrial-fibrillation-phase-3-100571113",false,"NCT06716021","ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3","Multi-Center, Placebo-Controlled, Phase 3 Study of Etripamil Nasal Spray (NS) in Patients With Atrial Fibrillation and Rapid Ventricular Rate (RVR)","ReVeRA-301","Inclusion Criteria:\n\n1. Age 18 years and over.\n2. Provision of written informed consent.\n3. Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.\n\n   * Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showing AF with ventricular rate ≥110 beats per minute (bpm). This ECG documentation (anonymized with study Patient ID only) will be submitted to the Sponsor after screening and prior to randomization to confirm diagnosis of AF with RVR and eligibility to be randomized in the study. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must have documented AF with RVR post-ablation for study eligibility.\n4. Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of AF with elevated (perceived or measured) heart rate (HR).\n\n   * Documentation: Patient description, other history, or medical records. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must fulfill this criterion post-ablation for study eligibility.\n5. Receiving appropriate antithrombotic\u002Fanticoagulation therapy as per applicable national and\u002For local guidelines for AF management.\n6. Women of childbearing potential must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of contraception from time of randomization until 7 days after the last administration of study drug and must be willing to discontinue from the study should they become or plan to become pregnant.\n\nExclusion Criteria:\n\n1. Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with AF who have been observed to also experience atrial flutter within the same episode (i.e., \"AFib\u002FFlutter\" or an admixture of AF and flutter within the same episode) are eligible.\n2. History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria; ischemic chest pain during AF episodes; acute coronary syndrome, unless the patient has been successfully revascularized; coronary artery bypass grafting or open-chest valve surgery.\n3. History of heart failure (HF) New York Heart Association (NYHA) classification ≥Class III within the last 3 months.\n\n   * The etiology of any HF should have been previously evaluated and addressed.\n   * HF with a reduced ejection fraction and\u002For HF with a preserved ejection fraction are acceptable.\n4. History of hemodynamic instability during AF, i.e., symptoms or signs of severe hypotension, or syncope due to a pause upon conversion from AF to sinus rhythm (SR).\n5. History of unexplained syncope.\n6. History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular (AV) block bradycardia (\\\u003C40 bpm) or pauses \\>3 seconds during waking hours, without a pacemaker.\n7. History of, or ECG evidence at the Screening visit, of: torsades de pointes, ventricular fibrillation, or ventricular tachycardia, Brugada syndrome, an antegrade conducting accessory bypass tract (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), or long QT syndrome.\n8. History of stroke, transient ischemic attack or peripheral embolism within the last 3 months.\n9. CHA2DS2-VASc score of \\>5.\n10. Planned AF or AV node ablation within the next 3 months.\n11. Uncorrected, severe aortic or mitral stenosis.\n12. Hypertrophic cardiomyopathy with outflow tract obstruction.\n13. History of sensitivity to verapamil or to any components of the investigational product.\n14. History of recent or current chronic alcohol or drug abuse that, in the opinion of the Investigator, could impact the validity of the study results.\n15. Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening.\n16. Any other significant co-morbid condition that may negatively impact the patient's participation in the study or likely result in non-compliance.","ALL","18 Years",{"count":20,"type":21},750,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit.\n\nEach patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study.\n\nInformed consent will be obtained prior to any study procedures.",[27],"Atrial Fibrillation",[27,29,30,31],"Rapid Ventricular Rate","Rapid Ventricular Response","Ventricular Rate Control","NOT_YET_RECRUITING","2026-01-13",{"date":35,"type":36},"2026-01-14","ACTUAL",{"date":38,"type":21},"2027-01",{"date":40,"type":21},"2030-01",{"name":42,"class":43},"Milestone Pharmaceuticals Inc.","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100497953","phase-2-the-node-202-study-study-of-etripamil-nasal-spray-in-pediatric-patients-100497953","NCT05763953","The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)","The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia","Inclusion Criteria:\n\nPatients will be eligible for study participation if they meet all of the following criteria at screening:\n\n1. Male or female patients\n\n   1. Part 1: patients 12 to \\\u003C18 years of age\n   2. Part 2: patients 6 to \\\u003C12 years of age\n2. Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age\n3. History of PSVT documented by ECG or other monitoring modality (e.g., Holter monitor, event recorder) showing SVT involving the Atrioventricular (AV) node (i.e., Atrioventricular nodal reentry tachycardia (AVNRT) or Atrioventricular reentrant tachycardia (AVRT)). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation\n4. Signed written informed consent\u002Fassent obtained\n5. Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria:\n\n   1. Negative pregnancy test at screening\n   2. Adequate contraception, unless total abstinence is used\n6. Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n1. History or presence of any of the following at the screening visit:\n\n   1. Patients with a history of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, atrial tachycardia) are not eligible\n   2. Permanent junctional reciprocating tachycardia\n   3. Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome)\n   4. Second- or third-degree AV block\n   5. Sick sinus syndrome or clinically significant bradycardia (\\\u003C50 bpm or equivalent in this patient population) on the resting ECG\n   6. Ventricular tachycardia\n   7. Long QT syndrome\n   8. Major structural heart disease (e.g., Ebstein's anomaly, corrected congenital heart disease) or symptoms of congestive heart failure (New York Heart Association class II to IV).\n2. Evidence of impaired liver function (alanine aminotransferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] \\>3 x upper limit of normal for age and gender) at the Screening Visit\n3. Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of \\\u003C15 mL\u002Fmin\u002F1.73m2, or requiring hemodialysis;\n4. Treatment with any of the following that cannot or will not be discontinued during study participation:\n\n   1. Any investigational drug within 60 days prior to study drug administration\n   2. IV beta-adrenergic blocking drugs (e.g., propranolol, esmolol), calcium channel blocking drugs (e.g., verapamil, diltiazem) or amiodarone within 24 hours prior to study drug administration\n   3. Oral amiodarone within 30 days prior to study drug administration\n   4. Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration\n   5. Any other drug that has a contraindication with verapamil\n5. Known hypersensitivity to verapamil or to any of the excipients of the study drug\n6. Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance\n7. History of hyperthyroidism\n8. Current pregnancy or breastfeeding","6 Years","17 Years",{"count":54,"type":21},60,[56],"PHASE2","NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.\n\nIn Part 1, at least 30 patients aged 12 to \\\u003C18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety\u002Ftolerability assessments (Part 1B).\n\nIn Part 2, at least 30 patients aged 6 to \\\u003C12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety\u002Ftolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety\u002Ftolerability assessments (Part 2B).\n\nThe study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up\u002FEnd of Study Visit.",[59],"Paroxysmal Supraventricular Tachycardia",[61],"PSVT","RECRUITING","2025-07-31",{"date":65,"type":36},"2025-08-01",{"date":67,"type":36},"2023-12-11",{"date":69,"type":21},"2027-06-30",{"name":42,"class":43},10,""]