Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2024-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

NCT06310642

AMS Acute Mountain Sickness

COMPLETED PHASE4

Sickness Evaluation at Altitude With Acetazolamide at Relative Doses

NCT03828474

Acute Mountain Sickness

COMPLETED PHASE1

A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

NCT01418157

Acute Mountain Sickness

COMPLETED PHASE4

Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years

NCT03561675

Acute Mountain Sickness

COMPLETED PHASE4

Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages

NCT03424226

Acute Mountain Sickness

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Mountain Sickness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective double-blind, placebo controlled randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This study will be a placebo-controlled, double blinded trial. Intervention and placebo are non-identical though very similar in appearance and will be stored in opaque vials. A non-blinded study team member will be solely in charge of dispensing medications.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prochlorperazine Maleate

This arm will be the interventional/experimental arm receiving prochlorperazine maleate, further described in experimental arm section.

Group Type EXPERIMENTAL

Prochlorperazine Maleate

Intervention Type 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.

Placebo

The placebo arm individuals will receive a non-identical placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prochlorperazine Maleate

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Compazine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes