Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852730
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-04-17
Brief Title:
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
Sponsor:
Repurposed Therapeutics Inc
Organization:
Repurposed Therapeutics Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg centrifuge parabolic flights andor Orion capsule recovery operations Astronaut participants may choose to test Inscop during provocative preflight training exercises eg centrifugation and can choose to take the medication prophylactically to prevent symptoms or after symptom onset to treat motion sickness during the launch andor 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 eg SpaceX Polaris Dawn Private Astronaut Missions eg 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 04 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 eg 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 eg 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 eg 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 tasks 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 eg 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 eg 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
This test may also involve non-astronaut test personnel during operational activities that involve provocative motion eg 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 tasks 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 eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None