CGRPR Antagonists and Acute Mountain Sickness

Phase 1

• Conditions: 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: 20.0Level: LLTClassification code 10020045Term: High altitude illnessSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2021-000592-36-DE
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-13
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%