Recruiting
Phase 2

Intranasal Scopolamine & Sensory Augmentation

Sponsor:

Repurposed Therapeutics, Inc.

Code:

NCT05852730

Conditions

Motion Sickness, Space

Motion Simulation

Parabolic Flight

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

DPI-386 Nasal Gel

Other (e.g., promethazine, meclizine)

Study Details

Brief summary:

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.

Conditions

Motion Sickness, Space

Motion Simulation

Parabolic Flight

Study ID

NCT05852730

Start date

Aug 10, 2021

Status verified date

May, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DPI-386 Nasal Gel

DPI-386 Nasal Gel, 0.4 mg

experimental: Control

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

Interventions

DPI-386 Nasal Gel

Subjects will self-administer DPI-386 Nasal Gel

Other (e.g., promethazine, meclizine)

Subjects will self-administer other medications as available.

Primary outcome measure

  • Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale. [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Locations

NASA Johnson Space Center Neuroscience Laboratory

Recruiting

Houston, Texas, United States, 77058

More Information

Sponsor

Repurposed Therapeutics, Inc.

Last update posted

May 16, 2024

Last verified

May, 2024

Keywords

  • Astronauts
  • centrifugation
  • parabolic
  • operational

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Repurposed Therapeutics, Inc. on 2024-05-16.