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.
The 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.
Fremanezumab 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.
This 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.
The 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.
Only 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.
This 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.
Age 18-60 years
No relevant previous illnesses in the preliminary examination
Written consent to participate in the study
Permanent residence <1000 m
Intolerance / allergy to Fremanzeumab or other drug components
Acute or chronic lung disease
Blood pressure systolic ≥150 mmHg or diastolic ≥95 mmHg (average of two measurements) in subjects with or without blood pressure medication
Pre-existing cardiovascular diseases other than arterial hypertension (coronary heart disease, heart failure, pulmonary hypertension, atrial fibrillation, peripheral arterial occlusive disease)
Parallel
Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution
DrugIntervention: Fremanezumab Single-dose subcutaneous fremanezumab 225 mg administered 7 days before ascent to high altitude (4554 m) for prevention of acute mountain sickness.
Placebo
DrugPlacebo Comparator: Placebo Single-dose subcutaneous placebo (1.5 mL 0.9% saline solution) administered 7 days before ascent to high altitude (4554 m).
Severity of acute mountain sickness as measured by the Lake Louise Score (LLS)
The Lake Louise Score is a validated symptom-based scoring system used to assess acute mountain sickness (AMS). It evaluates the presence and severity of typical AMS symptoms, including headache, gastrointestinal symptoms, fatigue or weakness, dizziness or light-headedness, and sleep disturbance. Each symptom is rated on a scale from 0 to 3, where 0 indicates absence of the symptom and 3 indicates severe symptoms. The total score ranges from 0 to 15, with higher scores indicating more severe AMS symptoms. In this study, the Lake Louise Score will be used to assess the incidence and severity of acute mountain sickness during exposure to high altitude. AMS is typically defined as the presence of headache together with a total Lake Louise Score of 3 or higher.
Incidence of acute mountain sickness
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