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

Launched by REPURPOSED THERAPEUTICS, INC. · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called intranasal scopolamine gel, which is being tested to help reduce motion sickness for astronauts and ground personnel during activities like training and space missions. The goal is to see how well this medication works when it is used before or after experiencing motion sickness, such as during parabolic flights or simulations. Participants, including astronauts from various missions, will also provide feedback on their symptoms and any side effects they may experience while using the medication.

To be eligible for this study, participants must be astronauts or personnel engaged in activities involving motion, and they should be free of certain medical conditions that could be worsened by the treatment. They will need to complete a COVID-19 test before participating and will be monitored closely during the trial. Those who join can expect to take the medication during training sessions and share their experiences, helping researchers understand its effectiveness and safety in real-world situations.

Gender

ALL

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.