search
Back to results

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

Primary Purpose

Motion Sickness, Space, Motion Sickness, Sea Sickness

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DPI-386 Nasal Gel
Placebo Nasal Gel
DPI-386 Nasal Gel
Placebo Nasal Gel
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 wave motion, eye-hand coordination, artificial horizon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects should be minimally susceptible to provocative motion as evidenced by at least two responses on the Motion Sickness Susceptibility Questionnaire of "Sometimes" or "Frequently." No participants should have 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. 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 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

DPI-386 Nasal Gel

Placebo Comparator

DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg

Placebo Comparator and Sensory Augmentation Placebo Nasal Gel

Arm Description

DPI-386 Nasal Gel, 0.4 mg

Placebo Nasal Gel

8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL

8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL

Outcomes

Primary Outcome Measures

Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale
The PDI scale ranges from 0 to 16 with higher numbers reflecting greater symptom severity (in this study a PDI score of 8 will be used as a motion sickness (MS) endpoint). During each session, the primary motion sickness symptoms will be recorded every minute during the capsule wave motion stimulation through the MS endpoint (PDI score ≥ 8 points) up to 45 min total.

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). This will be recorded at the same interval as the PDI score.
Time to MS endpoint (based on PDI score of 8 points)
The time to MS endpoint will be recorded once per session, range of 0-45 with higher numbers reflecting less motion sickness susceptibility.
Performance measures: response time
Response time during eye-hand coordination tasks will be recorded once every 15 min of stimulation (up to three measures per session) with the shorter response representing better performance.
Performance measures: error
Response error during eye -hand coordination tasks will be recorded once every 15 min of stimulation (up to three measures per session), with lower error representing better performance.

Full Information

First Posted
April 17, 2023
Last Updated
May 23, 2023
Sponsor
Repurposed Therapeutics, Inc.
Collaborators
National Aeronautics and Space Administration (NASA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05886660
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (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 is to evaluate the use of intranasal scopolamine gel and sensory augmentation as an integrated countermeasure to mitigate motion sickness and enhance sensorimotor performance. The proposed intranasal scopolamine gel formulation (Defender Pharmaceuticals, Inc.) offers a safe non-invasive method to self-administer with a rapid onset of action. This study involves a comparison of motion sickness outcome measures when administering intranasal scopolamine gel versus placebo (Aim 1a), and then when administering intranasal scopolamine gel versus placebo with a sensory augmentation belt (Aim 1b).
Detailed Description
The primary specific aim is to evaluate the use of intranasal scopolamine gel (DPI-386) and sensory augmentation (SA) as an integrated countermeasure to mitigate motion sickness and enhance sensorimotor performance. The proposed intranasal scopolamine gel formulation (Defender Pharmaceuticals, Inc.) offers a safe non-invasive method to self-administer with a rapid onset of action. The proposed sensory augmentation will utilize vibrotactile feedback of pitch and roll tilt using a portable belt (Engineering Acoustics, Inc.). The investigators will utilize exposure to simulated capsule wave motion on a 6DOF platform to provide an operationally relevant platform to induce motion sickness and impair performance on functional tasks. The investigators hypothesize that the combination of intranasal scopolamine gel and sensory augmentation of Earth vertical will be more effective to mitigate motion sickness and improve task performance than when administered separately. Using a randomized double-blind cross-over design, the investigators will compare motion sickness symptom severity and time to endpoint (symptom level defined as severe malaise) in 30 subjects during exposure to simulated wave motion on a 6DOF platform inside of a crew capsule mockup. The investigators will compare four conditions: (1) intranasal scopolamine gel (0.4 mg) with sensory augmentation, (2) intranasal scopolamine gel (0.4 mg) without sensory augmentation, (3) placebo control with sensory augmentation, and (4) placebo control without sensory augmentation. The wave motion stressor will begin 30 min post drug administration and will not exceed 45 min in duration. Performance on a series of functional tasks (dual-task tracking and eye-hand target acquisition) will be performed pre, during, immediately post, and following 15 min of recovery of each test. The bioavailability of scopolamine for each session will be estimated from plasma concentrations obtained at drug administration and then every 15 min up to 2-hr post-dosage. Subjective side effects and performance on the Psychomotor Vigilance Test (PVT) will also be obtained at 15 min intervals. A small pilot study including 10 subjects tested once each will be performed to verify the experimental protocol including that the simulated capsule wave motion will provoke motion sickness symptoms. These pilot sessions will not include the medication nor the blood sampling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness, Space, Motion Sickness, Sea Sickness
Keywords
wave motion, eye-hand coordination, artificial horizon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
A randomized double-blind (subjects and test operators) cross-over design.
Allocation
Randomized
Enrollment
30 (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
Placebo Comparator
Arm Type
Experimental
Arm Description
Placebo Nasal Gel
Arm Title
DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg
Arm Type
Experimental
Arm Description
8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL
Arm Title
Placebo Comparator and Sensory Augmentation Placebo Nasal Gel
Arm Type
Experimental
Arm Description
8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL
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)
Placebo Nasal Gel
Intervention Description
Subjects will self-administer Placebo Nasal Gel.
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. Vibrotactile feedback of tilt direction and magnitude will be provided on a sensory augmentation belt worn by the subject.
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Gel
Intervention Description
Subjects will self-administer Placebo Nasal Gel. Vibrotactile feedback of tilt direction and magnitude will be provided on a sensory augmentation belt worn by the subject.
Primary Outcome Measure Information:
Title
Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale
Description
The PDI scale ranges from 0 to 16 with higher numbers reflecting greater symptom severity (in this study a PDI score of 8 will be used as a motion sickness (MS) endpoint). During each session, the primary motion sickness symptoms will be recorded every minute during the capsule wave motion stimulation through the MS endpoint (PDI score ≥ 8 points) up to 45 min total.
Time Frame
45 minutes
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). This will be recorded at the same interval as the PDI score.
Time Frame
45 minutes
Title
Time to MS endpoint (based on PDI score of 8 points)
Description
The time to MS endpoint will be recorded once per session, range of 0-45 with higher numbers reflecting less motion sickness susceptibility.
Time Frame
45 minutes
Title
Performance measures: response time
Description
Response time during eye-hand coordination tasks will be recorded once every 15 min of stimulation (up to three measures per session) with the shorter response representing better performance.
Time Frame
45 minutes
Title
Performance measures: error
Description
Response error during eye -hand coordination tasks will be recorded once every 15 min of stimulation (up to three measures per session), with lower error representing better performance.
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects should be minimally susceptible to provocative motion as evidenced by at least two responses on the Motion Sickness Susceptibility Questionnaire of "Sometimes" or "Frequently." No participants should have 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. 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

We'll reach out to this number within 24 hrs