Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

August 5, 2024

Primary Completion Date

August 28, 2024

Study Completion Date

August 28, 2024

Conditions
Acute Mountain Sickness
Interventions
DRUG

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.

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.

Trial Locations (1)

80439

Mount Blue Sky, Evergreen

All Listed Sponsors
lead

University of Colorado, Denver

OTHER

NCT06450899 - Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness | Biotech Hunter | Biotech Hunter