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

Launched by REPURPOSED THERAPEUTICS, INC. · May 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people who experience motion sickness, which can happen during activities like traveling by car, boat, or even in space. The researchers are testing a gel called intranasal scopolamine that is applied inside the nose, along with a special sensory belt that enhances balance and movement. The goal is to see if this combination can reduce feelings of motion sickness and improve how well people can respond physically during motion. Participants will be compared against a group receiving a similar treatment without the active ingredients, which helps the researchers understand how effective the gel and belt are.

To participate in this study, candidates should be aged between 6 and 74 years and have some history of motion sickness, but they should not have certain medical conditions like severe eye problems or neurological disorders. They should also not be taking other medications that can affect the nervous system. If eligible, participants will undergo testing to ensure they are healthy and will receive the treatment in a safe setting. It’s important to note that pregnant women cannot take part in this trial. Overall, this study aims to find a safe and effective way to help those who struggle with motion sickness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects should be minimally susceptible to provocative motion as evidenced by at least two responses on the Motion Sickness Susceptibility Questionnaire of "Sometimes" or "Frequently."
• • 2. No participants should have 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.
• 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.