A Phase 3 interventional study of Scopolamine and Placebo Nasal Gel in Motion Sickness, sponsored by Repurposed Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Repurposed Therapeutics, Inc. · Phase 3, Interventional, and Treatment
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI 386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness in Senior Subjects With Open-Label Follow-Up
This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study with open-label follow-up to identify the safety, efficacy and pharmacokinetics of a repeated-dose regimen of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will have two arms: DPI-386 nasal gel and placebo nasal gel for Treatment Day 1. Treatment Day 1 will include 50 subjects per arm, for a total of 100 subjects (n=100). All 100 subjects from Treatment Day 1 will receive open-label DPI-386 Nasal Gel for Treatment Days 2-4 (50 of these were originally randomized to receive placebo prior to receipt of the investigational product.).
Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment and within 30 days of Treatment Day 1, Treatment Days 2-4 will take place at the clinical site.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 98 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Repurposed Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Agreement to adhere to the following lifestyle compliance considerations:
Exclusion Criteria:
Currently prescribed any of the following medication types and used within the specified below:
Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed by the PI or qualified designee:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DPI-386 Nasal Gel (0.2 mg / 0.12 g)
Drug: Scopolamine
placebo nasal gel (0.12 g)
Other: Placebo Nasal Gel
Subjects will self-administer DPI-386 Nasal Gel (0.2 mg / 0.12 g) or placebo nasal gel (0.12 g) on Treatment Day 1, and on Treatment Days 2 -4 all subjects will self administer DPI-386 Nasal Gel (0.2 mg / 0.12 g).
Also known as: DPI-386 Nasal Gel
Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication) during an 8 hour voyage on Treatment Day 1.
Time frame: During voyage on Treatment Day 1.
Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.
Safety endpoint is the incidence of adverse events.
Time frame: During all four Treatment Days
Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period.
Respondents specify their degree of nausea by indicating a point along a continuous 100 mm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and a higher score means more severe degree of nausea (Spinks \& Wasiak, 2011).
Time frame: During Treatment Day 1 voyage.
Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT).
The PVT is a neurocognitive assessment that measures alertness and tests sustained attention and reaction time. It was originally developed for sleep studies, and involves simple reaction time testing by requiring the participant to push a button as soon as the stimulus (a light) appears. After a response, the reaction time (in ms) is displayed. The inter-stimulus interval varies from two to 10 seconds, so it is not predictable, and the entire task takes 10 minutes (Dorrian, Rogers, \& Dinges, 2005). There are also shorter versions which have been validated as reasonable substitutes for the 10 minute version, such as the five minute (Lamond, Dawson, \& Roach, 2005)) and three minute versions (Grant, et al., (2017).
Time frame: During Treatment Day 1 voyage
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
PK parameters to be measured by Maximum Observed Plasma Concentration (Cmax)
Time frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
PK parameters to be measured by Time to Reach Maximum Observed Plasma Concentration (Tmax).
Time frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
PK parameters to be measured by Area Under the Curve (AUC)
Time frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
Plan to share: No — Publication
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Nov 2020, 17 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Scopolamine
Repurposed Therapeutics, Inc.