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Anticholinergic

DPI-386 Nasal Gel for Motion Sickness

Phase 3
Waitlist Available
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 during all four treatment days
Awards & highlights

Study Summary

This study is evaluating whether a nasal gel may help reduce nausea for individuals who are susceptible to motion sickness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during treatment days 2-4.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during treatment days 2-4. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
Secondary outcome measures
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT).
Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DPI-386 Nasal GelActive Control1 Intervention
DPI-386 Nasal Gel (0.2 mg / 0.12 g)
Group II: Placebo Nasal GelPlacebo Group1 Intervention
placebo nasal gel (0.12 g)

Find a Location

Who is running the clinical trial?

Repurposed Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,671 Total Patients Enrolled
9 Trials studying Motion Sickness
1,541 Patients Enrolled for Motion Sickness
David R HeltonStudy DirectorRepurposed Therapeutics, Inc.
2 Previous Clinical Trials
232 Total Patients Enrolled
1 Trials studying Motion Sickness
102 Patients Enrolled for Motion Sickness

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects
2019. "Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03988530.
~17 spots leftby Apr 2025
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