Clinical trial NCT06450899: Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
Official title: Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Mountain Sickness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective double-blind, placebo controlled randomized controlled trial
Primary purpose: PREVENTION

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Mountain Sickness
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Evergreen
country: United States
facility: Mount Blue Sky
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Elan Small, MD
role: STUDY_DIRECTOR
References: