Clinical Research Directory

Calcitonin Gene-related Peptide Antibody in Acute Mountain Sickness

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.

HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase

Prospective cohort study investigating the menstrual cycle phase (MCP)-dependent incidence of acute mountain sickness (AMS) in women travelling to 3600 m.

Voluntary Isocapnic Hyperpnea in Hypoxia to Mitigate Acute Mountain Sickness

This study investigates the effects of a brief Voluntary Isocapnic Hyperpnoea (VIH) on Acute Mountain Sickness (AMS) symptoms, SpO₂, blood pressure, and blood gas homeostasis in normobaric hypoxia, to evaluate whether such respiratory modulation may serve as a viable strategy to alleviate AMS symptoms. The investigation seeks to explore the physiological mechanisms underlying VIH in severe hypoxia (4200m asl) and furnish insight regarding practical means of providing immediate relief from AMS symptoms. Furthermore, given the scarcity of relevant literature, this investigation may serve as a pilot study and lay the foundation for future research. The present investigation employed a randomized crossover design. The study was conducted in the Institute of Sport - National Research Institute in Warsaw, Poland, in July and August 2025. Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. The order of sessions was determined using block randomization within subgroups of 4-6 individuals to ensure balanced exposure to each condition. Multiple measurements were taken, including blood pressure, heart rate, SpO2, blood gasometry, and the 2018 Lake Louise AMS Score.

EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill

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.