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

Primary Purpose

Motion Sickness, Space, Motion Simulation, Parabolic Flight

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DPI-386 Nasal Gel
Other (e.g., promethazine, meclizine)
Sponsored by
Repurposed Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness, Space focused on measuring Astronauts, centrifugation, parabolic, operational

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • NASA Johnson Space Center Neuroscience LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DPI-386 Nasal Gel

Control

Arm Description

DPI-386 Nasal Gel, 0.4 mg

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Motion sickness symptom severity using a Subjective Discomfort Rating (SDR).
The SDR scale ranges from 0-20 with higher numbers reflecting greater symptom severity (20 = vomiting).
Vertigo severity
Vertigo severity on a score (from 0 = none to 3 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Headache severity
Headache severity on a score (from 0 = none to 3 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Drowsiness severity
Drowsiness severity on a score (from 0 = none to 3 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)
Subjective rating of motion sickness impacts to performance of functional tasks (from 0 = none to 4 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).

Full Information

First Posted
April 17, 2023
Last Updated
May 9, 2023
Sponsor
Repurposed Therapeutics, Inc.
Collaborators
National Aeronautics and Space Administration (NASA)
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1. Study Identification

Unique Protocol Identification Number
NCT05852730
Brief Title
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
Official Title
Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance. Motion Sickness Countermeasures Field Test
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repurposed Therapeutics, Inc.
Collaborators
National Aeronautics and Space Administration (NASA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The primary specific aim is to evaluate the use of intranasal scopolamine gel (DPI-386) in operational field settings. Both astronauts and non-astronaut participants in the field testing will be recruited to test the feasibility and efficacy of the intranasal scopolamine gel (0.4 mg dosage). This testing will include only the active drug (no placebo); however, control astronaut subjects will also be recruited who choose other motion sickness countermeasures. The goal is to recruit astronauts from free-flier missions like SpaceX Polaris Dawn (8 active, 8 control), from Private Astronaut Missions to the International Space Station (ISS) like Axiom (8 active, 8 control), and from standard missions to the International Space Station (8 active, 8 control). Astronaut participants who choose to take intranasal scopolamine gel will be required to complete a 15 min training session to learn how to apply the medication, and then a 15 min debrief on any symptoms, side effects and comments on the efficacy and feasibility of self-administering the medication. Astronaut participants will also have the option to self-administer the drug during preflight activities that involve exposure to a motion environment (e.g., centrifuge training). For each time subjects choose to self-administer the drug, subjects will be asked to complete a short 15 min survey to describe the operational environment (e.g., centrifuge levels), any symptoms subjects experienced, side effects and comment s on the efficacy and feasibility of self-administering the medication. All astronauts, both active and control, will be tasked to complete a short inflight and postflight survey (15-30 min each) to summarize symptoms by day, record what medications were taken, rate their effectiveness, and summarize their recommendations on what others can do (or avoid) to improve recovery. This test may also involve non-astronaut test personnel during operational activities that involve provocative motion, e.g., capsule recovery simulations, centrifuge training, and parabolic flights. Participants for this part of the study will be recruited from personnel who are already involved and medically cleared for these operational activities and are interested in trying the drug to prevent or treat symptoms in addition to their primary task(s). In order to participate in these field test activities, subjects will be required to complete a 15 min training session to learn how to apply the medication, and then a 15 min debrief on any side effects and comments on the efficacy and feasibility of self-administering the medication. To prevent motion sickness, participants will administer the medication at least 30-45 min before the motion starts (e.g., centrifuge, launch, re-entry). To use the medication to treat motion sickness, participants will administer the medication while symptoms are still mild. Following the operational exercise, a short survey will be used to obtain the timing of the administration relative to the motion stressor, the operational environmental conditions (e.g., sea state or centrifugation levels), description of motion sickness symptoms and side effects, and subjective comments about the feasibility and efficacy of intranasal scopolamine gel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness, Space, Motion Simulation, Parabolic Flight
Keywords
Astronauts, centrifugation, parabolic, operational

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPI-386 Nasal Gel
Arm Type
Experimental
Arm Description
DPI-386 Nasal Gel, 0.4 mg
Arm Title
Control
Arm Type
Experimental
Arm Description
Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)
Intervention Type
Drug
Intervention Name(s)
DPI-386 Nasal Gel
Other Intervention Name(s)
scopolamine
Intervention Description
Subjects will self-administer DPI-386 Nasal Gel
Intervention Type
Drug
Intervention Name(s)
Other (e.g., promethazine, meclizine)
Intervention Description
Subjects will self-administer other medications as available.
Primary Outcome Measure Information:
Title
Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale.
Description
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).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Motion sickness symptom severity using a Subjective Discomfort Rating (SDR).
Description
The SDR scale ranges from 0-20 with higher numbers reflecting greater symptom severity (20 = vomiting).
Time Frame
1 week
Title
Vertigo severity
Description
Vertigo severity on a score (from 0 = none to 3 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Time Frame
1 week
Title
Headache severity
Description
Headache severity on a score (from 0 = none to 3 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Time Frame
1 week
Title
Drowsiness severity
Description
Drowsiness severity on a score (from 0 = none to 3 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Time Frame
1 week
Title
Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)
Description
Subjective rating of motion sickness impacts to performance of functional tasks (from 0 = none to 4 = severe) will be obtained once for each of the first three inflight days and once for each of the first three postflight days when space motion sickness is present, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Helton
Phone
949-981-6442
Email
dhelton@defenderpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott J Wood, PhD
Organizational Affiliation
National Aeronautics and Space Administration (NASA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
NASA Johnson Space Center Neuroscience Laboratory
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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