- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852730
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: David Helton
- Phone Number: 949-981-6442
- Email: dhelton@defenderpharma.com
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77058
- Recruiting
- NASA Johnson Space Center Neuroscience Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DPI-386 Nasal Gel
DPI-386 Nasal Gel, 0.4 mg
|
Subjects will self-administer DPI-386 Nasal Gel
Other Names:
|
Experimental: Control
Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)
|
Subjects will self-administer other medications as available.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale.
Time Frame: 1 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motion sickness symptom severity using a Subjective Discomfort Rating (SDR).
Time Frame: 1 week
|
The SDR scale ranges from 0-20 with higher numbers reflecting greater symptom severity (20 = vomiting).
|
1 week
|
Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)
Time Frame: 1 week
|
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).
|
1 week
|
Vertigo severity
Time Frame: 1 week
|
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).
|
1 week
|
Headache severity
Time Frame: 1 week
|
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).
|
1 week
|
Drowsiness severity
Time Frame: 1 week
|
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).
|
1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott J Wood, PhD, National Aeronautics and Space Administration (NASA)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Motion Sickness
- Space Motion Sickness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anesthetics, Local
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Mydriatics
- Diphenhydramine
- Promethazine
- Meclizine
- Scopolamine
Other Study ID Numbers
- NASA 0354 (Aim 2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Motion Sickness, Space
-
Repurposed Therapeutics, Inc.National Aeronautics and Space Administration (NASA)RecruitingMotion Sickness | Sea Sickness | Motion Sickness, SpaceUnited States
-
Faisal_Karmali@MEEI.HARVARD.EDUMassachusetts Institute of Technology; National Space Biomedical Research InstituteCompleted
-
Naval Aeromedical Research Unit, DaytonUnknownPrevention of Nausea Associated With Motion Sickness | Treatment of Nausea Associated With Motion SicknessUnited States
-
Wingate Institute of NeurogastroenterologyCompletedVisually Induced Motion Sickness in Healthy VolunteersUnited Kingdom
-
University Hospital, CaenCompleted
-
United States Army Aeromedical Research LaboratoryAlabama College of Osteopathic Medicine; Department of Aviation Medicine, U...CompletedMotion SicknessUnited States
-
Repurposed Therapeutics, Inc.TerminatedMotion SicknessUnited States
-
Dartmouth-Hitchcock Medical CenterRecruiting
-
Vanda PharmaceuticalsRecruitingMotion SicknessUnited States
-
Mayo ClinicRecruiting
Clinical Trials on DPI-386 Nasal Gel
-
Repurposed Therapeutics, Inc.TerminatedMotion SicknessUnited States
-
Repurposed Therapeutics, Inc.CompletedMotion SicknessUnited States
-
Repurposed Therapeutics, Inc.National Aeronautics and Space Administration (NASA)RecruitingMotion Sickness | Sea Sickness | Motion Sickness, SpaceUnited States
-
Repurposed Therapeutics, Inc.Defender Pharmaceuticals, Inc.CompletedMotion SicknessUnited States
-
Repurposed Therapeutics, Inc.CompletedMotion SicknessUnited States
-
Repurposed Therapeutics, Inc.CompletedMotion SicknessUnited States
-
Naval Aeromedical Research Unit, DaytonUnknownPrevention of Nausea Associated With Motion Sickness | Treatment of Nausea Associated With Motion SicknessUnited States
-
Acerus Pharmaceuticals CorporationCompletedFemale Sexual DysfunctionUnited States
-
Destiny Pharma PlcCompletedStaphylococcus Aureus InfectionUnited Kingdom
-
VA Office of Research and DevelopmentRecruiting