Acute Mountain Sickness (AMS) is a constellation of symptoms (headache, anorexia, nausea, vomiting, lightheadedness, and fatigue) occuring in unacclimatized mountaineers ascending too fast, too high MedDRA version: 20.0 Level: LLT Classification code 10020045 Term: High altitude illness System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Aimovig
Product Name: Erenumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcu
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-60 years - Good physical condition - No relevant pathologies revealed upon the pre-examination prior to the study - Written informed consent to participate in the study - Permanent residency below 1000 m - Males and females are included without prioritization - More than 3 weeks since vaccination against or full recovery from SARS-CoV2 infection - Negative serum or urine pregnancy test in women of childbearing potential if pregnancy cannot be ruled out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Intolerance against erenuma or any drug component - Acute and chronic lung diseases - Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease) - Conventional systolic blood pressure =150 mmHg and conventional diastolic blood pressure =95 mmHg (average of two measurements) in untreated or treated subjects - Chronic headache / migraine - Diabetes mellitus - Smoking (>6 cigarettes/day) or equivalent nicotine substitutes - Alcohol (>30 g/d) or drug abuse - Obesity (Body Mass Index >30) - Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders, Parkinson disease, pheochromocytoma) - Sojourn >2000 m within the last 8 weeks before the 1st study day - Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti-coagulants) - Blood donation within the last 2 month before the 1st study day - Pregnant or nursing women - Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does Erenumab reduce the severity of AMS after a 12-hours exposure to normobaric hypoxia at an oxygen concentration of 12% (corresponding to an altitude of 4500 m)?;Secondary Objective: Does Erenumab reduce the incidence of AMS after a 12-hours exposure to normobaric hypoxia at an oxygen concentration of 12% (corresponding to an altitude of 4500 m)?;Primary end point(s): Severity of AMS measured by the means of the Lake Louise Score;Timepoint(s) of evaluation of this end point: 12-hours after beginning of exposure to normobaric hypoxia at an oxygen concentration of 12% | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of AMS;Timepoint(s) of evaluation of this end point: 12-hours after beginning of exposure to normobaric hypoxia at an oxygen concentration of 12% | — |
Countries
Germany
Contacts
Public ContactSekretariat Anästhesiologie
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
Outcome results
None listed