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Anticholinergic

Transderm Scop® 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled and open label active-controlled study to identify the safety and efficacy of a repeated-dose regimen of DPI-386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of motion sickness. The study will be conducted aboard Navy fleet or Marine ships undergoing military operations to obtain data in an operationally relevant real world environment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of DPI-386 Nasal Gel
Cognition Disorders
Secondary outcome measures
Nausea
Safety of DPI-386 Nasal Gel in terms of cognition

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Transderm Scop®Experimental Treatment1 Intervention
TDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days.
Group II: DPI-386 nasal gelActive Control1 Intervention
DPI-386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.1 g dose, with each dose therefore described as "0.2 mg / 0.1 g"
Group III: placebo nasal gelPlacebo Group1 Intervention
Placebo nasal gel product is the same but does not contain scopolamine HBr

Find a Location

Who is running the clinical trial?

Repurposed Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,469 Total Patients Enrolled
9 Trials studying Motion Sickness
1,339 Patients Enrolled for Motion Sickness
David HeltonStudy DirectorRepurposed Therapuetics, Inc.
3 Previous Clinical Trials
666 Total Patients Enrolled
3 Trials studying Motion Sickness
666 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
Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
2019. "Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04272255.
All > Motion Sickness
~50 spots leftby Apr 2025
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