A Phase 2 interventional study of Prochlorperazine Maleate and Placebo in Acute Mountain Sickness, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Prevention
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).
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.
192 studies on the registry are indexed under Altitude Sickness; 45 are open to participants now.
This study's enrollment of 57 is above the median of 34 across 159 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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This arm will be the interventional/experimental arm receiving prochlorperazine maleate, further described in experimental arm section.
Drug: Prochlorperazine Maleate
The placebo arm individuals will receive a non-identical placebo.
Drug: Placebo
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
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.
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.
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.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prochlorperazine
University of Colorado, Denver →