Intranasal Scopolamine for Motion Sickness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a nasal gel treatment called intranasal scopolamine to determine its effectiveness in preventing or reducing motion sickness in astronauts and ground crew during space-related activities. The goal is to assess the treatment's efficacy and practicality for real-life situations, such as space missions or motion simulations. Participants will use either this nasal gel or other common motion sickness medications for comparison. This trial suits astronauts or crew members involved in activities with significant motion, like simulations or parabolic flights, who do not have certain medical conditions such as glaucoma or urinary retention. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
Participants must stop taking medications that affect the central nervous system, like antihistamines, tricyclic antidepressants, and muscle relaxants, before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatment under testing, called intranasal scopolamine, appears safe. In earlier studies, participants used DPI-386 Nasal Gel (another name for intranasal scopolamine) and experienced only minor side effects. The FDA granted it a Priority Review for preventing motion sickness, indicating a positive safety profile.
In other studies focused on preventing nausea and vomiting, many participants did not experience vomiting within four hours of using the gel. This suggests that most people tolerate the treatment well. No major negative effects were reported in these studies, which boosts confidence in its safety.
Overall, while some risk always exists, the evidence so far supports that intranasal scopolamine is generally safe, especially for those dealing with motion sickness.12345Why are researchers excited about this trial's treatments?
Intranasal Scopolamine is unique because it offers a new delivery method for motion sickness relief. Unlike traditional options like promethazine or meclizine, which are usually taken orally, this treatment is administered through the nose as a nasal gel. This method could provide faster relief and be more convenient for people who have difficulty swallowing pills. Researchers are excited about its potential to offer quick and effective relief with fewer side effects, making it a promising alternative to existing treatments.
What evidence suggests that this trial's treatments could be effective for motion sickness?
Research has shown that intranasal scopolamine, administered as DPI-386 Nasal Gel in this trial, helps reduce motion sickness symptoms. It significantly lowers the chances of nausea and vomiting. The nasal gel acts quickly, even when the stomach isn't moving normally, a common occurrence during motion sickness. It has proven more effective than a placebo in easing moderate to severe nausea. The gel begins working within 15 minutes, making it a fast-acting option. Another treatment arm in this trial includes a control group receiving other preventative or treatment medications for motion sickness, such as promethazine or meclizine.13678
Who Is on the Research Team?
Scott J Wood, PhD
Principal Investigator
National Aeronautics and Space Administration (NASA)
Are You a Good Fit for This Trial?
This trial is for astronauts and test personnel who experience motion during their duties, like in simulations or parabolic flights. They must not have neurological disorders, narrow-angle glaucoma, urinary retention issues, or a recent positive COVID-19 test.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training and Initial Testing
Participants complete a 15 min training session to learn how to apply the medication and a 15 min debrief on symptoms, side effects, and comments on efficacy and feasibility.
Operational Testing
Participants administer the medication during operational activities involving provocative motion (e.g., centrifuge training, parabolic flights) and complete surveys on symptoms and side effects.
Follow-up
Participants complete inflight and postflight surveys to summarize symptoms, record medications taken, and provide recommendations.
What Are the Treatments Tested in This Trial?
Interventions
- Intranasal Scopolamine
- Meclizine
- Promethazine
- Sensory Augmentation
Intranasal Scopolamine is already approved in United States for the following indications:
- Motion sickness
- Postoperative nausea and vomiting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Repurposed Therapeutics, Inc.
Lead Sponsor
National Aeronautics and Space Administration (NASA)
Collaborator