Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

NCT06450899 | Completed Phase 2 FDA Drug

• 1 other identifier: 23-0958
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Mountain Sickness

Outcome Measures

Primary Outcomes (1)

• Acute Mountain Sickness

  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.

  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.

Study Arms (2)

Prochlorperazine Maleate

EXPERIMENTAL

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

Drug: Prochlorperazine Maleate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Also known as: Compazine

Prochlorperazine Maleate

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Mount Blue Sky

Evergreen, Colorado, 80439, United States

Location

Related Publications (1)

• Small E, Goldberg E, Musi M, Strickland B, Paterson R, Phillips C, Keyes LE. Prochlorperazine maleate versus placebo for the prevention of acute mountain sickness: study protocol for a randomized controlled trial. Trials. 2024 Nov 21;25(1):785. doi: 10.1186/s13063-024-08592-x.

  PMID: 39574186 DERIVED

MeSH Terms

Conditions

Altitude Sickness

Interventions

Prochlorperazine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elan Small, MD

  University of Colorado, Denver

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective double-blind, placebo controlled randomized controlled trial

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 10, 2024
• Study Start: August 5, 2024
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)