Using intranasal scopolamine gel to reduce motion sickness in astronauts and ground-control subjects

Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance. Motion Sickness Countermeasures Field Test

This study is testing if a nasal gel can help astronauts and regular people feel less sick during movements like spinning or flying.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Repurposed Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05852730 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and effectiveness of intranasal scopolamine gel (DPI-386) in preventing and treating motion sickness among astronauts and ground-control participants exposed to provocative motion environments, such as centrifuge simulations and parabolic flights. Participants will self-administer the gel during training sessions and missions, with a focus on monitoring symptoms and side effects through debrief questionnaires. The study aims to gather data on the operational use of the medication in real-world settings, comparing its effects against other motion sickness countermeasures.

Who should consider this trial

Good fit: Ideal candidates include astronauts assigned to space missions or personnel involved in motion simulation activities.

Not a fit: Patients with neurologic, vestibular, or autonomic disorders, or those taking CNS-affecting medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce motion sickness symptoms for astronauts during critical mission phases, enhancing their performance and safety.

How similar studies have performed: While the use of scopolamine for motion sickness is established, this specific application in operational settings with astronauts is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Subjects will involve astronauts assigned to spaceflight missions or test personnel assigned to operational activities that involve provocative motion (e.g., simulations or parabolic flights).
2. No participants should have no neurologic, vestibular or autonomic disorders, or medical conditions that could be worsened by scopolamine (narrow-angle glaucoma or urinary retention)
3. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test \< 7 days prior to study drug administration or no COVID 19 symptoms up to 10 days prior to study drug administration.

Note: There are no accepted forms of terrestrial motion analogs that adequately predict susceptibility to space motion sickness so none will be used in this field test.

Exclusion Criteria:

1. Subjects will be excluded if they are taking other drugs that are capable of causing CNS effects such as antihistamines, tricyclic antidepressants, and muscle relaxants or have hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system.
2. Pregnant women are excluded from participation. Women of child-bearing potential will be offered a pregnancy screening test and excluded with a positive test.

Where this trial is running

Houston, Texas

• NASA Johnson Space Center Neuroscience Laboratory — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Scott J Wood, PhD — National Aeronautics and Space Administration (NASA)
• Study coordinator: Barry Feinberg, MD

Conditions Motion Sickness, Space; Motion Simulation; Parabolic Flight; Astronauts; centrifugation; parabolic; operational