Clinical trial NCT06310642: Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
Official title: A Prospective Single-Blinded Randomized Field-Based Trial to Evaluate the Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: AMS
Acute Mountain Sickness
Keywords: Prochlorperazine
AMS
LLAMS Score
Acute Mountain Sickness
Lead sponsor: CHRISTUS Health
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled a cohort of consenting, healthy subjects aged \>17 years. Thirty subjects enrolled in the study. 15 subjects received prochlorperazine. 15 subjects received placebo.
Primary purpose: TREATMENT

Brief summary: A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.

Detailed description: This was a prospective, single-blinded, field-based interventional trial involving consenting, healthy subjects aged \>17 years. The study was conducted on the big Island of Hawaii, at sea level and at the summit of Mauna Kea volcano. Following randomization, subjects received either placebo or 10mg prochlorperazine, then immediately drove for 2 hours from sea level to the volcano summit (4205m). Participants spent 240 min at the summit, and they recorded their symptoms. AMS was defined by the previously validated Lake Louise Acute Mountain Sickness Score (LLAMS). Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.

Eligibility criteria: Inclusion Criteria - Healthy subjects aged \>17 years

Exclusion criteria-subject meets any of the following:

* Known allergy or contraindication to the study drug.
* Known or suspected pregnancy.
* Use of another analgesic or antiemetic within 8 hours of enrollment.
* History of chronic headaches.
* Inability to provide informed consent.
* Use of central nervous system depressants, including alcohol, opiates, and/or barbiturates, within 24 hours of the study start time.
* History of severe depression.
* History of dementia.
* Prior ascent and stay at 2500m for duration over 6 weeks within 30 days prior.

Primary outcomes:
measure: Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups
timeFrame: LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)
Secondary outcomes:
measure: Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups
timeFrame: LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency
state: Texas
Study officials:
affiliation: CHRISTUS Health
name: Peter Richman, MD
role: PRINCIPAL_INVESTIGATOR
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