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

NCT05852730 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NASA 0354 (Aim 2)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Astronauts; centrifugation; parabolic; operational

Outcome Measures

Primary Outcomes (1)

• Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale.

  The maximum nausea score (from 0 = none to 3 = severe) will be recorded once for each of the first three inflight days and once for each of the first three postflight days, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).

  1 week

Secondary Outcomes (5)

• Motion sickness symptom severity using a Subjective Discomfort Rating (SDR).

  1 week

• Vertigo severity

  1 week

• Headache severity

  1 week

• Drowsiness severity

  1 week

• Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)

  1 week

Study Arms (2)

DPI-386 Nasal Gel

EXPERIMENTAL

DPI-386 Nasal Gel, 0.4 mg

Drug: DPI-386 Nasal Gel

Control

EXPERIMENTAL

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

Drug: Other (e.g., promethazine, meclizine)

Interventions

DPI-386 Nasal Gel DRUG

Subjects will self-administer DPI-386 Nasal Gel

Also known as: scopolamine

DPI-386 Nasal Gel

Other (e.g., promethazine, meclizine) DRUG

Subjects will self-administer other medications as available.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

NASA Johnson Space Center Neuroscience Laboratory

Houston, Texas, 77058, United States

RECRUITING

MeSH Terms

Conditions

Space Motion Sickness

Interventions

Scopolamine; Promethazine; Meclizine

Condition Hierarchy (Ancestors)

Motion Sickness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Propylamines; Amines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Scott J Wood, PhD

  National Aeronautics and Space Administration (NASA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barry Feinberg, MD

CONTACT

314-697-1330; bfeinberg@defenderpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 10, 2023
• Study Start: August 10, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)