Intranasal Scopolamine for Motion Sickness

Overseen By Barry Feinberg, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Repurposed Therapeutics, Inc.

Must not be taking: Antihistamines, Antidepressants, Muscle relaxants

Disqualifiers: Neurologic, Vestibular, Autonomic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 6 7 8}

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

I am an astronaut assigned to a space mission or involved in motion testing.

I tested negative for COVID-19 recently or have had no symptoms for 10 days.

I do not have any neurological, balance, or specific health issues that could worsen with scopolamine.

Exclusion Criteria

Pregnant women are excluded from participation. Women of child-bearing potential will be offered a pregnancy screening test and excluded with a positive test.

I am not taking medications like antihistamines, antidepressants, or muscle relaxants that affect the brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 week

1 visit (in-person)

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.

1 week

Multiple visits (in-person) during operational activities

Follow-up

Participants complete inflight and postflight surveys to summarize symptoms, record medications taken, and provide recommendations.

1 week

Surveys completed during and after operational activities

What Are the Treatments Tested in This Trial?

Interventions

• Intranasal Scopolamine
• Meclizine
• Promethazine
• Sensory Augmentation

Trial Overview

The study tests an intranasal scopolamine gel (DPI-386) against other treatments like promethazine to prevent or treat motion sickness in spaceflight-related activities. Participants will use the medication in real operational settings and provide feedback.

How Is the Trial Designed?

Group I: DPI-386 Nasal Gel Experimental Treatment 1 Intervention

DPI-386 Nasal Gel, 0.4 mg

Group II: Control Experimental Treatment 1 Intervention

Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)

Intranasal Scopolamine is already approved in United States for the following indications:

Approved in United States as Transdermal Scopolamine for:

• Motion sickness
• Postoperative nausea and vomiting

Who Is Running the Clinical Trial?

Repurposed Therapeutics, Inc.

Lead Sponsor

Trials

11

Recruited

1,800+

National Aeronautics and Space Administration (NASA)

Collaborator

Trials

32

Recruited

1,900+

Published Research Related to This Trial

Intranasal scopolamine (INSCOP) significantly improved tolerance to motion sickness in 16 susceptible subjects, allowing them to endure more head movements compared to a placebo, indicating its efficacy as a treatment.

The intranasal formulation was absorbed rapidly, reaching measurable plasma levels within 15 minutes, and did not cause significant cognitive or sedative side effects, making it a safe alternative for motion sickness prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of low-dose intranasal scopolamine for motion sickness. Simmons, RG., Phillips, JB., Lojewski, RA., et al.[2019]

Intranasal scopolamine (IN SCOP) was found to significantly increase the time participants could tolerate motion compared to a placebo, indicating its potential efficacy for treating motion sickness.

The study showed that while IN SCOP has a longer time to reach maximum concentration (Tmax) than some other intranasal drugs, it still holds promise as a rapid treatment option, although further research is needed to optimize its formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal Scopolamine for Motion Sickness. Stankovic, AS., Alvarenga, DL., Coleman Daniels, VR., et al.[2020]

The novel in situ gel formulation of scopolamine hydrobromide (SCOP) for nasal delivery was found to be safe, showing no nasal ciliotoxicity, and demonstrated prolonged residence time in the nasal cavity compared to traditional methods.

In a study involving rats, the intranasal SCOP gel significantly reduced motion sickness symptoms more effectively than subcutaneous and oral administration, indicating its potential as a superior treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of ion-activated in situ gel systems of scopolamine hydrobromide and evaluation of its antimotion sickness efficacy. Cao, SL., Zhang, QZ., Jiang, XG.[2022]

Intranasal scopolamine gel (INSCOP) was tested in a study with 12 healthy subjects and showed dose-linear pharmacokinetics, meaning that higher doses led to proportionally higher drug levels in the blood.

All doses of INSCOP were well tolerated with no serious side effects, indicating that it is a fast, reliable, and safe alternative for treating space motion sickness compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation pharmacokinetics of intranasal scopolamine gel formulation. Wu, L., Boyd, JL., Daniels, V., et al.[2018]

A new formulation of scopolamine nasal spray was found to be effective in treating motion sickness, significantly reducing seasickness scores compared to placebo and dimenhydrinate in a study involving a randomized, double-blind, crossover design.

The nasal spray demonstrated a fast onset of action within 30 minutes and showed no signs of nasal or epipharyngeal irritation, indicating it is a safe and well-tolerated option for motion sickness treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scopolamine nasal spray in motion sickness: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo. Klöcker, N., Hanschke, W., Toussaint, S., et al.[2019]

Transdermal scopolamine (Transderm-Scop) is effective for preventing motion sickness and has a lower risk of central nervous system (CNS) side effects compared to oral scopolamine, making it a safer option for many users.

However, CNS side effects can still occur, particularly in elderly patients or those with certain preexisting conditions, and diagnosing these side effects can be challenging due to the patch's location and delayed symptom onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal scopolamine-induced psychosis. Ziskind, AA.[2019]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05548270

Efficacy and Safety of DPI-386 Nasal Gel for the Prevention ...

The purpose of this study (DPI-386-MS-33) is to prospectively evaluate the difference in the rate of complete response, defined as no vomiting and no rescue ...

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defenderpharma.com/resource/defender-pharmaceuticals-phase-3-motion-sickness-trial-results-selected-for-presentation-at-2023-military-health-system-research-symposium-mhsrs/

Defender Pharmaceuticals Phase 3 Motion Sickness Trial ...

Subjects receiving DPI-386 (intranasal scopolamine gel) demonstrated significantly lower incidence of nausea, vomiting or the need for ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31666152/

Intranasal Scopolamine for Motion Sickness

Intranasal scopolamine (IN SCOP) is attractive because it can be fast acting and work when gastric motility is slowed.

4.

empr.com

empr.com/home/news/drugs-in-the-pipeline/intranasal-scopolamine-gets-priority-review-for-motion-sickness-prevention/

Intranasal Scopolamine Gets Priority Review for Motion ...

Additionally, intranasal scopolamine was found to be significantly more effective at reducing moderate to severe nausea than placebo (P <.0001).

5.

apps.dtic.mil

apps.dtic.mil/sti/tr/pdf/ADA503148.pdf

Efficacy of Intranasal Scopolamine Gel for Motion Sickness ...

The results of the blood plasma data showed a moderate level of systemically available scopolamine beginning at the first collection time point (15 minutes ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04219982

Study Details | NCT04219982 | DPI 386 Nasal Gel for the ...

At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire ...

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT03920644/study-of-the-safety-and-efficacy-of-dpi-386-nasal-gel-on-ocean-going-vessels?mp=AngelCare&page=4&id=310&slug=stomach-discomfort

Study of the Safety and Efficacy of DPI-386 Nasal Gel on ...

At least minimally susceptible to provocative motion as evidenced by a minimumscore of 3.0 on the MSSQ. In good general health as evidenced by ...

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defenderpharma.com

defenderpharma.com/therapeutic-areas/lead-indication/

Lead Indication

... Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated with Motion. Participants who report no vomiting within 4 hours after ...