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

Trial Summary

What is the purpose of this trial?

The primary specific aim of this Field Test aim is to evaluate the feasibility and efficacy of administering the intranasal scopolamine gel in operational field settings using both astronaut and ground-control subjects that are exposed to provocative motion as part of their assigned duties. For the ground-control subjects, these may include motion simulations (e.g., centrifuge), parabolic flights and/or Orion capsule recovery operations. Astronaut participants may choose to test Inscop during provocative preflight training exercises (e.g., centrifugation), and can choose to take the medication prophylactically to prevent symptoms or after symptom onset to treat motion sickness during the launch and/or landing mission phases. Both ground-control and astronaut participants will be required to test the medication during a training session to monitor for adverse side effects. Participants in the field test aim will complete short debrief questionnaires to capture motion sickness symptoms, side effects, and feasibility comments. The investigators will also include field "control" subjects who did not take (INSCOP) to comment on what countermeasures subjects used and their effectiveness. The investigators will be recruiting astronaut participants from free-flier missions (e.g., SpaceX Polaris Dawn), Private Astronaut Missions (e.g., Axiom), and standard missions to the International Space Station.

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.

What data supports the effectiveness of the drug intranasal scopolamine for motion sickness?

Research shows that intranasal scopolamine is effective for motion sickness, with studies indicating it works faster and is more effective than some other treatments like dimenhydrinate. It has been shown to reduce symptoms significantly within 30 minutes of administration, making it a fast and reliable option. ^{1 2 3 4 5}

Is intranasal scopolamine safe for humans?

Intranasal scopolamine has been found to be safe in studies, with no significant side effects like sleepiness or cognitive impairment reported. It was well tolerated in healthy subjects, and no unexpected or serious adverse effects were observed. ^{1 2 3 4 6}

How is intranasal scopolamine different from other motion sickness drugs?

Intranasal scopolamine is unique because it is administered through the nose, allowing for faster absorption and quicker relief from motion sickness compared to oral or transdermal forms, which are absorbed more slowly. ^{1 2 3 4 6}

Research Team

Scott J Wood, PhD

Principal Investigator

National Aeronautics and Space Administration (NASA)

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The efficacy of low-dose intranasal scopolamine for motion sickness. [2019]

2. Netherlands 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Dose escalation pharmacokinetics of intranasal scopolamine gel formulation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Intranasal Scopolamine for Motion Sickness. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Preparation of ion-activated in situ gel systems of scopolamine hydrobromide and evaluation of its antimotion sickness efficacy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Transdermal scopolamine-induced psychosis. [2019]