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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I do not have conditions like glaucoma or issues with urination that could worsen with scopolamine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 minutes for reporting.

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) symptom severity using Pensacola Diagnostic Index (PDI) scale
Secondary outcome measures
Motion sickness symptom severity using a Subjective Discomfort Rating (SDR)
Performance measures: error
Performance measures: response time
+1 more

Trial 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
24 Previous Clinical Trials
1,736 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

Intranasal Scopolamine Gel (Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT05886660 — Phase 2
Motion Sickness Research Study Groups: Placebo Comparator and Sensory Augmentation Placebo Nasal Gel, DPI-386 Nasal Gel, Placebo Comparator, DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg
Motion Sickness Clinical Trial 2023: Intranasal Scopolamine Gel Highlights & Side Effects. Trial Name: NCT05886660 — Phase 2
Intranasal Scopolamine Gel (Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05886660 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What types of patients are qualified to join this clinical research program?

"In order to be a part of this research, prospective patients must suffer from motion sickness and fall within the age bracket of 18-65. The goal is to recruit 30 people in total for the study."

Answered by AI

What is the current enrollment capacity for this scientific research?

"Yes, information on clinicaltrials.gov confirms that this medical trial is actively receiving applicants. First posted on January 21st 2022 and last modified May 23rd 2023, the study aims to recruit 30 individuals at one clinic site."

Answered by AI

Are there any openings left for prospective volunteers to join this experiment?

"According to clinicaltrials.gov, this trial is now in the process of patient enrollment and was initially posted on January 21st 2022. The most updated information has been added as recent as May 23rd 2023."

Answered by AI

Does the trial accept participants aged 25 and above?

"The eligibility criteria for this medical trial restricts applicants to between 18 and 65 years old. Separately, there are 1 study available to minors and 4 studies open to seniors."

Answered by AI

Has the FDA officially sanctioned DPI-386 Nasal Gel?

"Despite the lack of data regarding efficacy, there is sufficient evidence to consider DPI-386 Nasal Gel's safety as a 2 on our team's scale."

Answered by AI

Who else is applying?

What site did they apply to?
NASA Johnson Space Center Neuroscience Laboratory
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have never found a motion sickness solution that has worked. Scopolamine patches have come the closest but it is not a full solution for me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
2022. "Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05886660.
All > Motion Sickness
~4 spots leftby Sep 2024
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