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Anticholinergic
Intranasal Scopolamine + Sensory Augmentation 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
No participants should have neurologic, vestibular or autonomic disorders, or medical conditions that could be worsened by scopolamine (narrow-angle glaucoma or urinary retention
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 minutes
Summary
This trial will evaluate a nasal gel and sensory belt to reduce motion sickness and improve sensorimotor performance. The gel is a safe, non-invasive way to self-administer with quick results.
Who is the study for?
This trial is for people who sometimes or frequently get motion sickness, as per the Motion Sickness Susceptibility Questionnaire. They shouldn't have neurological, vestibular, autonomic disorders, narrow-angle glaucoma, urinary retention issues or COVID-19 symptoms.
What is being tested?
The study tests intranasal scopolamine gel against a placebo to see if it can reduce motion sickness and improve sensorimotor skills. Participants will also try a sensory augmentation belt with both treatments to compare effects.
What are the potential side effects?
Scopolamine may cause dry mouth, drowsiness, dizziness and blurred vision. Since it's administered nasally in this trial, there might be local irritation or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have conditions like glaucoma or issues with urination that could worsen with scopolamine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 minutes
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) symptom severity using Pensacola Diagnostic Index (PDI) scale
Secondary study objectives
Motion sickness symptom severity using a Subjective Discomfort Rating (SDR)
Performance measures: error
Performance measures: response time
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Placebo Comparator and Sensory Augmentation Placebo Nasal GelExperimental Treatment1 Intervention
8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL
Group II: Placebo ComparatorExperimental Treatment1 Intervention
Placebo Nasal Gel
Group III: DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mgExperimental Treatment1 Intervention
8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL
Group IV: DPI-386 Nasal GelExperimental Treatment1 Intervention
DPI-386 Nasal Gel, 0.4 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Nasal Gel
2019
Completed Phase 3
~100
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
1,739 Total Patients Enrolled
9 Trials studying Motion Sickness
1,609 Patients Enrolled for Motion Sickness
National Aeronautics and Space Administration (NASA)FED
31 Previous Clinical Trials
1,860 Total Patients Enrolled
2 Trials studying Motion Sickness
128 Patients Enrolled for Motion Sickness
Scott J Wood, PhDPrincipal InvestigatorNational Aeronautics and Space Administration (NASA)
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Motion Sickness
80 Patients Enrolled for Motion Sickness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I tested negative for COVID-19 recently or have had no symptoms for 10 days.I do not have conditions like glaucoma or issues with urination that could worsen with scopolamine.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Comparator and Sensory Augmentation Placebo Nasal Gel
- Group 2: DPI-386 Nasal Gel
- Group 3: Placebo Comparator
- Group 4: DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg
Awards:
This trial has 0 awards, including: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.