Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

This study is a trial looking at a drug to help prevent acute mountain sickness. The drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. Participants will either take the drug or a placebo, and hike to and sleep at the summit of Mount Blue Sky located at 4,348 meters (14,265 feet).

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Key information

Conditions

Acute Mountain Sickness Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mount Blue Sky

Evergreen, Colorado, 80439, United States

About this study

This study will be a double-blind randomized controlled trial to investigate the utility of prochlorperazine maleate versus placebo for the chemoprophylaxis of acute mountain sickness on rapid ascent to 4,348 meters, specifically the summit of Mount Blue Sky in the Mount Blue Sky Wilderness. Participants will be evaluated for AMS utilizing the 2018 LLQ both the evening of and morning after ascent. The primary outcome will be the presence of AMS, defined by a 2018 LLQ score equal to or greater than 3, including the presence of a headache at any measured point during the study. Individuals will convene the morning of the study in Golden, Colorado where they will receive breakfast and either placebo or prochlorperazine. They will then be driven to Summit Lake where they will break for lunch and receive the second dose of placebo or prochlorperazine. They will then hike to the Mount Blue Sky summit where they will receive their third and final dose of either placebo or intervention, spend the night in the structures at the summit, and be assessed for AMS via LLQ. In the morning, they will be assessed for AMS again, receive breakfast, and then be driven back to the original meeting point. They will be monitored by Emergency Physicians at all points during the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults >18 years old.

Exclusion criteria

Individuals <18 years old or >75 years old
Pregnant women
Individuals who reside at or have slept at elevations >1,800 meters in the last two weeks
Individuals having taken acetazolamide, steroids, ibuprofen, anti-emetics or additional analgesics within the last 24 hours prior to study initiation
Individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia
Individuals with known allergies to prochlorperazine or phenothiazines
Individuals taking medications with significant medication interactions with prochlorperazine: Dofetilide, potassium acid phosphate, potassium chloride, potassium citrate, potassium phosphate, Yohimbe.
Individuals with a history of dementia
Individuals who lack decision making capacity

Treatment and study plan

Prochlorperazine Maleate

Drug

Currently, prochlorperazine maleate is approved by the FDA for the treatment of nausea and vomiting, and additionally used off-label as an acute migraine treatment. The FDA has approved the dose of 5-10 mg to be taken orally 3-4 times a day. The study intervention will be obtained from Belmar Pharma solutions. Individuals randomized into the study arm will receive generic prochlorperazine maleate 10 mg orally taken three times daily for one day. Participants will convene in the morning of the trial date at low altitude, where they will receive their first dose. They will then be driven to Summit Lake and break for lunch, where they will receive their second dose approximately 6 hours later. They will then hike to the summit and receive their final dose in the evening, approximately another 6 hours later.

Other names: Compazine

Placebo

Drug

The placebo arm individuals will receive a non-identical inert generic placebo tablet containing microcrystalline cellulose provided by Belmar Pharma Solutions. Placebo tablets will be taken at the same time and frequency as the study intervention drug.

Primary outcomes

Acute Mountain Sickness

Time frame: The primary outcome will be assessed during the discreet roughly 36 hour trial period. LLQs will be administered the evening of and morning after arrival to peak altitude, or at any point of self reported altitude illness.

The primary outcome will be the presence of AMS, defined by a 2018 Lake Louise Questionnaire (LLQ) score of equal to or greater than 3, including the presence of a headache at any measured point during the study.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 10, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed