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Migraine drug may stop altitude sickness before it starts

NCT ID NCT07653516

Prevention Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether a single injection of fremanezumab, a drug used to prevent migraines, can stop acute mountain sickness (AMS) in healthy adults. Thirty volunteers will receive either the drug or a placebo one week before climbing to a high-altitude hut. Researchers will track symptoms like headache and nausea to see if the drug reduces AMS severity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-60 years * No relevant previous illnesses in the preliminary examination * Written consent to participate in the study * Permanent residence \<1000 m * Men and women are included without prioritization * Negative urine pregnancy test if pregnancy cannot be ruled out with certainty Exclusion Criteria: * 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) * Chronic headache, migraine * Diabetes mellitus * Smoking (\>6 cigarettes/d) or equivalent nicotine substitution * Alcohol (\>30 g/d) or other drug abuse * Overweight (BMI \>30 kg/m2) * Other pre-existing conditions considered relevant by the investigators (liver disease, kidney disease, thyroid disease, Parkinson's disease, pheochromocytoma) * Stay \>2000 m altitude within the last 8 weeks before the first study day * 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). * Blood donation within the last 2 months before the first study day * Pregnancy or breastfeeding * Participation in other clinical studies

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Conditions

The condition(s) this trial relates to.

altitude sickness migraine disorder acute mountain sickness prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute mountain sickness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bern University Hospital

    Bern, 3010, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.