A Phase 2 interventional study of DPI-386 Nasal Gel and Other (e.g., promethazine, meclizine) in Motion Sickness, Space, Motion Simulation and Parabolic Flight, sponsored by Repurposed Therapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Repurposed Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
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.
Repurposed Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DPI-386 Nasal Gel, 0.4 mg
Drug: DPI-386 Nasal Gel
Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)
Drug: Other (e.g., promethazine, meclizine)
Subjects will self-administer DPI-386 Nasal Gel
Also known as: scopolamine
Subjects will self-administer other medications as available.
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).
Time frame: 1 week
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).
Time frame: 1 week
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).
Time frame: 1 week
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).
Time frame: 1 week
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).
Time frame: 1 week
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).
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Sep 2026, 61 months after the start.
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Studies of the drug tested here: DPI-386
Space Motion Sickness
Repurposed Therapeutics, Inc.