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Anticholinergic
Intranasal Scopolamine for Motion Sickness
Phase 2
Recruiting
Led By Scott J Wood, PhD
Research Sponsored by Repurposed Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Study Summary
This trial will test the feasibility & efficacy of administering intranasal scopolamine gel to astronauts & ground-controls exposed to motion simulations to prevent/treat motion sickness. Participants complete short questionnaires & discuss countermeasures used & effectiveness.
Who is the study for?
This trial is for astronauts and test personnel who experience motion during their duties, like in simulations or parabolic flights. They must not have neurological disorders, narrow-angle glaucoma, urinary retention issues, or a recent positive COVID-19 test.Check my eligibility
What is being tested?
The study tests an intranasal scopolamine gel (DPI-386) against other treatments like promethazine to prevent or treat motion sickness in spaceflight-related activities. Participants will use the medication in real operational settings and provide feedback.See study design
What are the potential side effects?
Scopolamine may cause side effects such as dry mouth, dizziness, blurred vision, and drowsiness. It's important that participants don't have conditions that could be exacerbated by these effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale.
Secondary outcome measures
Drowsiness severity
Headache severity
Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: DPI-386 Nasal GelExperimental Treatment1 Intervention
DPI-386 Nasal Gel, 0.4 mg
Group II: ControlExperimental Treatment1 Intervention
Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DPI-386 Nasal Gel
2021
Completed Phase 3
~750
Find a Location
Who is running the clinical trial?
Repurposed Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,689 Total Patients Enrolled
9 Trials studying Motion Sickness
1,559 Patients Enrolled for Motion Sickness
National Aeronautics and Space Administration (NASA)FED
24 Previous Clinical Trials
1,686 Total Patients Enrolled
2 Trials studying Motion Sickness
78 Patients Enrolled for Motion Sickness
Scott J Wood, PhDPrincipal InvestigatorNational Aeronautics and Space Administration (NASA)
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Motion Sickness
30 Patients Enrolled for Motion Sickness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications like antihistamines, antidepressants, or muscle relaxants that affect the brain.I am an astronaut assigned to a space mission or involved in motion testing.I tested negative for COVID-19 recently or have had no symptoms for 10 days.I do not have any neurological, balance, or specific health issues that could worsen with scopolamine.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: DPI-386 Nasal Gel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How reliable is the protection that DPI-386 Nasal Gel offers individuals?
"Although the data on efficacy is yet to be determined, DPI-386 Nasal Gel has obtained a score of 2 indicating that its safety profile has some clinical evidence."
Answered by AI
Are there still vacancies available to participate in this scientific inquiry?
"Indeed, the clinicaltrials.gov website confirms that this trial is actively enrolling participants. It was first published on August 10th 2021 and most recently modified on May 9th 2023. The research requires 80 volunteers to be recruited from one medical centre."
Answered by AI
How many individuals are participating in this medical research?
"Correct. According to clinicaltrials.gov, this research venture has been actively recruiting since its initial posting on August 10th 2021 and the most recent edit was made on May 9th 2023. This trial is hoping to enrol 80 subjects at a single medical site."
Answered by AI
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