[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-mountain-sickness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-mountain-sickness":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641319","phase-4-calcitonin-gene-related-peptide-antibody-in-acute-mountain-sickness-100641319",false,"NCT07653516","Calcitonin Gene-related Peptide Antibody in Acute Mountain Sickness","Calcitonin Gene-Related Peptide Antibody for Prevention of Acute Mountain Sickness: A Prospective Single-center, Randomized, Placebo-controlled, Double-blinded Study","Inclusion Criteria:\n\n* Age 18-60 years\n* No relevant previous illnesses in the preliminary examination\n* Written consent to participate in the study\n* Permanent residence \\\u003C1000 m\n* Men and women are included without prioritization\n* Negative urine pregnancy test if pregnancy cannot be ruled out with certainty\n\nExclusion Criteria:\n\n* Intolerance \u002F allergy to Fremanzeumab or other drug components\n* Acute or chronic lung disease\n* Blood pressure systolic ≥150 mmHg or diastolic ≥95 mmHg (average of two measurements) in subjects with or without blood pressure medication\n* Pre-existing cardiovascular diseases other than arterial hypertension (coronary heart disease, heart failure, pulmonary hypertension, atrial fibrillation, peripheral arterial occlusive disease)\n* Chronic headache, migraine\n* Diabetes mellitus\n* Smoking (\\>6 cigarettes\u002Fd) or equivalent nicotine substitution\n* Alcohol (\\>30 g\u002Fd) or other drug abuse\n* Overweight (BMI \\>30 kg\u002Fm2)\n* Other pre-existing conditions considered relevant by the investigators (liver disease, kidney disease, thyroid disease, Parkinson's disease, pheochromocytoma)\n* Stay \\>2000 m altitude within the last 8 weeks before the first study day\n* Medication taken within the last 2 months before the first study day, which could influence the data quality (e.g. corticosteroids) or the safety of the subjects (e.g. anticoagulation).\n* Blood donation within the last 2 months before the first study day\n* Pregnancy or breastfeeding\n* Participation in other clinical studies",true,"ALL","18 Years","60 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Acute mountain sickness (AMS) is a common condition that can occur when healthy people travel quickly to high altitude. Typical symptoms include headache, nausea, tiredness, dizziness, and poor sleep. In most cases, AMS improves with rest and by not climbing higher, but it can make mountaineering difficult and, in severe cases, can lead to dangerous complications.\n\nThe biological mechanisms that cause high-altitude headache and AMS are not yet fully understood. Some symptoms of AMS are similar to migraine, suggesting that both conditions may share common pathways in the nervous system. One possible pathway involves calcitonin gene-related peptide (CGRP), a substance known to play an important role in migraine.\n\nFremanezumab is an approved monoclonal antibody used to prevent migraine. It works by binding to CGRP and reducing its biological activity. This study will investigate whether a single dose of fremanezumab can also help prevent symptoms of AMS and high-altitude headache in healthy adults exposed to high altitude. To date, there are no clinical data on the effect of fremanezumab in AMS or high-altitude headache.\n\nThis is a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 30 healthy adult volunteers will participate. Participants will be randomly assigned in a 1:1 ratio to receive either a single subcutaneous injection of fremanezumab 225 mg or placebo (saline). Neither the participants nor the investigators will know which treatment was given during the study. The study medication will be administered 1 week before ascent to Capanna Regina Margherita at 4554 meters above sea level. Participants will remain there for 46 hours under hypobaric hypoxic conditions.\n\nThe main goal is to determine whether fremanezumab reduces the severity of AMS compared with placebo. AMS symptoms will be measured using the Lake Louise Score, a standard questionnaire commonly used in altitude medicine. Additional assessments will include the incidence of AMS, headache characteristics, safety outcomes, vital signs, oxygen saturation, and the use of rescue medication. Symptoms will be assessed repeatedly during the high-altitude stay.\n\nOnly healthy adults aged 18 to 60 years living below 1000 meters will be eligible. People with important medical conditions, chronic headache or migraine, relevant cardiovascular or lung disease, pregnancy, or recent high-altitude exposure will be excluded. Participants will be closely monitored during the study. Rescue medication, oxygen, and descent to lower altitude will be available if needed.\n\nThis study may help improve understanding of how AMS develops and whether CGRP blockade could become a new preventive strategy for high-altitude headache and AMS. It may also improve understanding of links between altitude-related headache and migraine.",[28],"Acute Mountain Sickness",[30,31,32],"acute mountain sickness","calcitonin gene-related peptide antibody","migraine","NOT_YET_RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":22},"2027-06-01",{"date":41,"type":22},"2027-07-31",{"name":43,"class":44},"Insel Gruppe AG, University Hospital Bern","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100556903","phase-2-elevation-care-a-randomized-controlled-trial-on-the-prevention-of-acute-mountain-sickness-with-suxiao-jiuxin-pill-100556903","NCT06531161","EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill","Safety and Efficacy of Suxiao Jiuxin Pill for Prevention of Acute Mountain Sickness: a Randomized Controlled Trial","EVEREST","Inclusion Criteria:\n\n* Healthy volunteers, aged 18-55 years old (including boundary values);\n* Female volunteers weighing ≥45.0 kg and male volunteers weighing ≥50.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm2 (including boundary values) (BMI=weight kg\u002Fheight m2);\n* Primary residence at an altitude of \\\u003C500 meters above sea level;\n* Not ascending to an altitude \\>2500 meters in the 6 months prior to the screening period;\n* Voluntary participation with written informed consent.\n\nExclusion Criteria:\n\n* Subjects with previous severe high altitude sickness such as high altitude heart disease, high altitude pulmonary edema, high altitude cerebral edema, and high altitude erythrocytosis;\n* Subjects with established cardiovascular or cerebrovascular disease or uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and\u002For diastolic blood pressure ≥ 90mmHg at screening);\n* Subjects with clinically significant respiratory disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, anemia, or acute infection;\n* Subjects with primary headache (migraine, tension headache, cluster headache, etc.) or secondary headache (headache associated with infection, cerebrovascular, etc.) within 1 month prior to screening;\n* Subjects with insomnia, anxiety, depression or a history of motion sickness or airplane sickness;\n* Subjects with Lake Louise Score ≥ 2 at screening;\n* Subjects with left index finger oxygen saturation \\\u003C95% at screening;\n* Subjects with alanine aminotransferase or aspartate aminotransferase \\> 2 times the upper limit of the normal range, or creatinine \\> upper limit of the normal range at screening;\n* Subjects with hypersensitive C-reactive protein \\> upper limit of normal range at screening;\n* Subjects with history of surgery or blood donation within 3 months prior to screening;\n* Subjects with any medication or non-pharmacological intervention (including dietary supplements) to prevent or treat acute mountain sickness within 14 days prior to screening;\n* Smoking ≥20 cigarettes per day within 3 months prior to screening;\n* Contraindications to the use of Suxiao Jiuxin Pill, such as allergies;\n* Women who are pregnant, breastfeeding, or have a positive pregnancy test (human chorionic gonadotropin test);\n* Alcohol abuse \\[more than 28 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL spirit with 40% alcohol by volume, or 150 mL of wine)\\] or substance abuse within 6 months prior to screening;\n* Participation in another interventional clinical study within 3 months prior to screening;\n* Other conditions, in the opinion of the investigators, make participation in this study inappropriate.","55 Years",{"count":56,"type":22},168,[58,59],"PHASE2","PHASE3","The aim of this randomized, controlled trial is to evaluate the safety and efficacy of Suxiao Jiuxin Pills for prevention of acute mountain sickness (AMS) after high altitude exposure in healthy volunteers, and its influences on physiological indicators before and after high altitude exposure.",[28],[28,63,64],"Suxiao Jiuxin Pill","Traditional Chinese Medicine","2024-08-08",{"date":67,"type":37},"2024-08-12",{"date":69,"type":22},"2024-08",{"date":71,"type":22},"2025-09",{"name":73,"class":44},"Peking University First Hospital"]