Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05886660

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 2024-05-17

30

Participants Needed

1

Research Sites

136 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 is to evaluate the use of intranasal scopolamine gel and sensory augmentation as an integrated countermeasure to mitigate motion sickness and enhance sensorimotor performance. The proposed intranasal scopolamine gel formulation (Defender Pharmaceuticals, Inc.) offers a safe non-invasive method to self-administer with a rapid onset of action. This study involves a comparison of motion sickness outcome measures when administering intranasal scopolamine gel versus placebo (Aim 1a), and then when administering intranasal scopolamine gel versus placebo with a sensory augmentation belt (Aim 1b).

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...

  • Subjects must report at least two responses of "Sometimes" or "Frequently" on the Motion Sickness Susceptibility Questionnaire
  • No neurologic, vestibular, or autonomic disorders
  • No medical conditions worsened by scopolamine such as narrow-angle glaucoma or urinary retention
  • Negative COVID-19 test within 7 days before drug administration or no symptoms up to 10 days before drug administration
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Taking drugs that affect the central nervous system, like antihistamines, tricyclic antidepressants, or muscle relaxants
  • Hypersensitivity to scopolamine, belladonna alkaloids, or any ingredient in the formulation or delivery system
  • 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

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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