Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05852730

Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance

Led by Repurposed Therapeutics, Inc. · Updated on 2024-05-16

80

Participants Needed

1

Research Sites

264 weeks

Total Duration

On this page

Sponsors

R

Repurposed Therapeutics, Inc.

Lead Sponsor

N

National Aeronautics and Space Administration (NASA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary specific aim of this Field Test aim is to evaluate the feasibility and efficacy of administering the intranasal scopolamine gel in operational field settings using both astronaut and ground-control subjects that are exposed to provocative motion as part of their assigned duties. For the ground-control subjects, these may include motion simulations (e.g., centrifuge), parabolic flights and/or Orion capsule recovery operations. Astronaut participants may choose to test Inscop during provocative preflight training exercises (e.g., centrifugation), and can choose to take the medication prophylactically to prevent symptoms or after symptom onset to treat motion sickness during the launch and/or landing mission phases. Both ground-control and astronaut participants will be required to test the medication during a training session to monitor for adverse side effects. Participants in the field test aim will complete short debrief questionnaires to capture motion sickness symptoms, side effects, and feasibility comments. The investigators will also include field "control" subjects who did not take (INSCOP) to comment on what countermeasures subjects used and their effectiveness. The investigators will be recruiting astronaut participants from free-flier missions (e.g., SpaceX Polaris Dawn), Private Astronaut Missions (e.g., Axiom), and standard missions to the International Space Station.

CONDITIONS

Official Title

Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Astronauts assigned to spaceflight missions or test personnel involved in operational activities with provocative motion (e.g., simulations, parabolic flights)
  • No neurologic, vestibular, or autonomic disorders
  • No medical conditions worsened by scopolamine such as narrow-angle glaucoma or urinary retention
  • Negative FDA-authorized COVID-19 test within 7 days before drug administration or no COVID-19 symptoms for 10 days prior
Not Eligible

You will not qualify if you...

  • Use of drugs causing CNS effects such as antihistamines, tricyclic antidepressants, or muscle relaxants
  • Hypersensitivity to scopolamine, belladonna alkaloids, or any ingredient in the medication
  • Pregnant women or women with a positive pregnancy test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NASA Johnson Space Center Neuroscience Laboratory

Houston, Texas, United States, 77058

Actively Recruiting

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Research Team

B

Barry Feinberg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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