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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale.
Secondary study objectives
Drowsiness severity
Headache severity
Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
National Aeronautics and Space Administration (NASA)FED
31 Previous Clinical Trials
1,810 Total Patients Enrolled
Scott J Wood, PhDPrincipal InvestigatorNational Aeronautics and Space Administration (NASA)
1 Previous Clinical Trials
30 Total Patients Enrolled
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.