Motion Sickness, SpacePhase 2NCT05886660
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
A Phase 2 study testing DPI-386 Nasal Gel in people with Motion Sickness, Space and Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness, Space, Motion Sickness, Sea Sickness
- What is being tested?
- DPI-386 Nasal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NASA Johnson Space Center Neuroscience Laboratory
Houston, Texas, 77058
About this study
Official title: Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
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).
Read the 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.
- Conditions
- Motion Sickness, Space, Motion Sickness, Sea Sickness
- Being tested
- DPI-386 Nasal Gel, Placebo Nasal Gel
- Keywords
- wave motion, eye-hand coordination, artificial horizon
- Medical subject headings
- Space Motion Sickness, Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPI-386 Nasal GelDrug
Also called scopolamine
Subjects will self-administer DPI-386 Nasal Gel.
Placebo Nasal GelDrug
Subjects will self-administer Placebo Nasal Gel.
DPI-386 Nasal GelDrug
Also called scopolamine
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.
Placebo Nasal GelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 Nasal Gel | Experimental | DPI-386 Nasal Gel, 0.4 mg Receives: Drug: DPI-386 Nasal Gel |
| Placebo Comparator | Experimental | Placebo Nasal Gel Receives: Drug: Placebo Nasal Gel |
| DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg | Experimental | 8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL Receives: Drug: DPI-386 Nasal Gel |
| Placebo Comparator and Sensory Augmentation Placebo Nasal Gel | Experimental | 8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL Receives: Drug: Placebo Nasal Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 minutes
Secondary outcomes (4)
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.
Measured: 45 minutes
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.
Measured: 45 minutes
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.
Measured: 45 minutes
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.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start21 Jan 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion Sickness, SpaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Responsible party
- Sponsor
- Investigators
- Scott J Wood, PhD, Principal investigator, National Aeronautics and Space Administration (NASA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886660
- Sponsor's protocol ID
- NASA 0354 (Aim 1)
- Status last verified
- May 2024
- First submitted
- 17 Apr 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
- ClinicalTrials.gov ID
- NCT05886660
- Acronym / sponsor ID
- NASA 0354 (Aim 1)
- Conditions
- Motion Sickness, Space, Motion Sickness, Sea Sickness
- Keywords
- wave motion, eye-hand coordination, artificial horizon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DPI-386 Nasal Gel | Experimental | Drug: DPI-386 Nasal GelDPI-386 Nasal Gel, 0.4 mg |
| Placebo Comparator | Experimental | Drug: Placebo Nasal GelPlacebo Nasal Gel |
| DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg | Experimental | Drug: DPI-386 Nasal Gel8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL |
| Placebo Comparator and Sensory Augmentation Placebo Nasal Gel | Experimental | Drug: Placebo Nasal Gel8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPI-386 Nasal GelAlso: scopolamineSubjects will self-administer DPI-386 Nasal Gel. | Drug | DPI-386 Nasal Gel |
| Placebo Nasal GelSubjects will self-administer Placebo Nasal Gel. | Drug | Placebo Comparator |
| DPI-386 Nasal GelAlso: scopolamineSubjects 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. | Drug | DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg |
| Placebo Nasal GelSubjects 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. | Drug | Placebo Comparator and Sensory Augmentation Placebo Nasal Gel |
Primary outcome
Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale
Time frame: 45 minutes
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.
4 secondary outcomes
Motion sickness symptom severity using a Subjective Discomfort Rating (SDR)
Time frame: 45 minutes
Time to MS endpoint (based on PDI score of 8 points)
Time frame: 45 minutes
Performance measures: response time
Time frame: 45 minutes
Performance measures: error
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott J Wood, PhD principal investigator
National Aeronautics and Space Administration (NASA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPI-386 Nasal Gel in people with Motion Sickness, Space and Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry Feinberg, MD (314-697-1330, bfeinberg@defenderpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.