Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

NCT06310642 | Completed Phase 4 FDA Drug

• 1 other identifier: 2020-217
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

AMS; Acute Mountain Sickness

Keywords

Prochlorperazine; AMS; LLAMS Score; Acute Mountain Sickness

Outcome Measures

Primary Outcomes (1)

• Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups

  The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. The primary outcome was the difference in mean LLAMS scores between the prochlorperazine and placebo groups (t-tests). Previously validated Lake Louise Acute Mountain Sickness Score (LLAMS) were utilized. Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.

  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 (1)

• Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups

  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)

Study Arms (2)

Prochlorperazine 10 mg

EXPERIMENTAL

Subjects received 10 mg Prochlorperazine one time.

Other: Immediate descent from altitude.; Drug: Diphenhydramine; Drug: Prochlorperazine 10 mg

Placebo

PLACEBO COMPARATOR

Subjects received Placebo one time.

Other: Immediate descent from altitude.; Drug: Diphenhydramine

Interventions

Immediate descent from altitude. OTHER

Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.

Placebo; Prochlorperazine 10 mg

Diphenhydramine DRUG

Diphenhydramine was available to counteract any potential extrapyramidal side effects of the study drug. The use of Diphenhydramine for this purpose is well established.

Also known as: Benadryl

Placebo; Prochlorperazine 10 mg

Prochlorperazine 10 mg DRUG

Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent

Prochlorperazine 10 mg

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency

Corpus Christi, Texas, 78405, United States

Location

Related Publications (8)

• Smedley T, Grocott MP. Acute high-altitude illness: a clinically orientated review. Br J Pain. 2013 May;7(2):85-94. doi: 10.1177/2049463713489539.

  PMID: 26516505 BACKGROUND

• Klocke DL, Decker WW, Stepanek J. Altitude-related illnesses. Mayo Clin Proc. 1998 Oct;73(10):988-92; quiz 992-3. doi: 10.4065/73.10.988.

  PMID: 9787751 BACKGROUND

• Irons HR, Salas RN, Bhai SF, Gregorie WD, Harris NS. Prospective Double-Blinded Randomized Field-Based Clinical Trial of Metoclopramide and Ibuprofen for the Treatment of High Altitude Headache and Acute Mountain Sickness. Wilderness Environ Med. 2020 Mar;31(1):38-43. doi: 10.1016/j.wem.2019.11.005. Epub 2020 Feb 11.

  PMID: 32057631 BACKGROUND

• Luks AM, Auerbach PS, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Acute Altitude Illness: 2019 Update. Wilderness Environ Med. 2019 Dec;30(4S):S3-S18. doi: 10.1016/j.wem.2019.04.006. Epub 2019 Jun 24.

  PMID: 31248818 BACKGROUND

• Netzer N, Strohl K, Faulhaber M, Gatterer H, Burtscher M. Hypoxia-related altitude illnesses. J Travel Med. 2013 Jul-Aug;20(4):247-55. doi: 10.1111/jtm.12017. Epub 2013 Mar 11.

  PMID: 23809076 BACKGROUND

• Lu H, Wang R, Xiong J, Xie H, Kayser B, Jia ZP. In search for better pharmacological prophylaxis for acute mountain sickness: looking in other directions. Acta Physiol (Oxf). 2015 May;214(1):51-62. doi: 10.1111/apha.12490. Epub 2015 Mar 28.

  PMID: 25778288 BACKGROUND

• Kanaan NC, Peterson AL, Pun M, Holck PS, Starling J, Basyal B, Freeman TF, Gehner JR, Keyes L, Levin DR, O'Leary CJ, Stuart KE, Thapa GB, Tiwari A, Velgersdyk JL, Zafren K, Basnyat B. Prophylactic Acetaminophen or Ibuprofen Results in Equivalent Acute Mountain Sickness Incidence at High Altitude: A Prospective Randomized Trial. Wilderness Environ Med. 2017 Jun;28(2):72-78. doi: 10.1016/j.wem.2016.12.011. Epub 2017 May 4.

  PMID: 28479001 BACKGROUND

• Olson LG, Hensley MJ, Saunders NA. The effects of combined morphine and prochlorperazine on ventilatory control in humans. Am Rev Respir Dis. 1986 Apr;133(4):558-61. doi: 10.1164/arrd.1986.133.4.558.

  PMID: 3963624 BACKGROUND

MeSH Terms

Conditions

Altitude Sickness

Interventions

Diphenhydramine; Prochlorperazine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Richman, MD

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were blinded in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Research Director, Department of Emergency Medicine

Model Details: Enrolled a cohort of consenting, healthy subjects aged \>17 years. Thirty subjects enrolled in the study. 15 subjects received prochlorperazine. 15 subjects received placebo.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: March 15, 2024
• Study Start: May 20, 2021
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)