Motion SicknessPhase 3NCT04272255
Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
A Phase 3 study testing scopolamine HBr and Transdermal Scopolamine in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- scopolamine HBr and Transdermal Scopolamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated ICD.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 59 (inclusive).
- Active duty military or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by PI or qualified designee prior to signing the ICD.
- At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
- In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as recommended by the PI or qualified designee.
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- Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
- For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. Test must be negative.
- Agreement to adhere to the following lifestyle compliance considerations:
- Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the six treatment days.
- Abstain from alcohol for 24 hours prior to first dose of study medication and during the six Treatment Days.
Who cannot join
- Pregnancy, lactation, or positive urine pregnancy test at screening.
- Known allergic reactions to scopolamine or other anticholinergics.
- Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
- Hospitalization or significant surgery requiring hospital admittance within the past six months.
- Treatment with another investigational drug or other intervention within the past 30 days.
- Having donated blood or plasma or suffered significant blood loss within the past 30 days.
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- Having any of the following medical conditions within the last two years or deemed clinically significant by the PI or qualified designee as being exclusionary:
- Significant gastrointestinal disorder, asthma, or seizure disorders.
- History of vestibular disorders.
- History of narrow-angle glaucoma.
- History of urinary retention problems.
- History of alcohol or drug abuse.
- Nasal, nasal sinus, or nasal mucosa surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NAMRU-D
Dayton, Ohio, 45433
Matthew Doubravo, MD, 937-938-3915, matthew.doubravo@us.af.mil
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
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.
Read the detailed description
The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.5 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 100 subjects per arm, for a total of 300 subjects (n=300). Multiple ships and ships' crews will be used, until the required enrollment is completed. The DPI-386 Nasal Gel and placebo nasal gel arms will be double-blinded, whereas the TDS arm will remain unblinded. Both DPI-386 Nasal Gel and placebo nasal gel will be administered twice daily over the six consecutive Treatment Days. The two daily doses of DPI-386 Nasal Gel or placebo nasal gel will be separated by a minimum of six hours ± 15 minutes, and will occur during the subject's on-duty period. The TDS patch will be administered on Treatment Days 1 and 4.
- Conditions
- Motion Sickness
- Being tested
- scopolamine HBr, Transdermal Scopolamine
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scopolamine HBrDrug
Nasal Gel
Transdermal ScopolamineDrug
Patch
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 nasal gel | Active comparator | 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" Receives: Drug: scopolamine HBr |
| placebo nasal gel | Placebo comparator | Placebo nasal gel product is the same but does not contain scopolamine HBr Receives: Drug: scopolamine HBr |
| Transderm Scop® | Experimental | 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. Receives: Drug: Transdermal Scopolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of DPI-386 Nasal Gel
Compare the efficacy of DPI-386 Nasal Gel (0.2 mg scopolamine HBr per dose, maximum of two doses per day, for a maximum of six doses over three consecutive days) with that of the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ) scores over the treatment period across all three treatment arm. Sixteen symptoms are listed, with symptoms differentiated along four dimensions: gastrointestinal, central, peripheral, and sopite-related. Each symptom is scored from 1 to 9 in severity and scores then calculated. All 16 items were collected from the general public instead of experts, allowing for a more accurate wording of the symptomology experienced by persons outside of hysiological sciences.
Measured: 3 days
Safety of DPI-386 Nasal Gel in terms of cognitive effects
Compare the safety of DPI-386 Nasal Gel with that of the TDS patch and placebo nasal gel, with an emphasis on cognitive effects by incidence of treatment related adverse events.
Measured: 24 hours
Secondary outcomes (2)
Efficacy of DPI-386 and severe nausea
Compare the efficacies of DPI-386 Nasal Gel, TDS patch, and placebo nasal gel in severity of nausea. Respondents specify their degree of nausea by indicating a point along a continuous 100mm 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. Severity of nausea will measured by the Nausea Assessment (Visual Analog Scale) (VAS)) over the treatment period.
Measured: 3 days
Safety of DPI-386 Nasal Gel in terms of cognition
Compare the safety of DPI-386 Nasal Gel with that of TDS patch and placebo nasal gel in terms of cognition as measured by the Psychomotor Vigilance Tests (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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start22 Apr 2019
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Helton, Study director, Repurposed Therapuetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272255
- Sponsor's protocol ID
- DPI-386-MS-08
- Status last verified
- Feb 2020
- First submitted
- 14 Dec 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
- ClinicalTrials.gov ID
- NCT04272255
- Acronym / sponsor ID
- DPI-386-MS-08
- Conditions
- Motion Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.5 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 100 subjects per arm, for a total of 300 subjects (n=300). Multiple ships and ships' crews will be used, until the required enrollment is completed. The DPI-386 Nasal Gel and placebo nasal gel arms will be double-blinded, whereas the TDS arm will remain unblinded. Both DPI-386 Nasal Gel and placebo nasal gel will be administered twice daily over the six consecutive Treatment Days. The two daily doses of DPI-386 Nasal Gel or placebo nasal gel will be separated by a minimum of six hours ± 15 minutes, and will occur during the subject's on-duty period. The TDS patch will be administered on Treatment Days 1 and 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DPI-386 nasal gel | Active comparator | Drug: scopolamine HBrDPI-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" |
| placebo nasal gel | Placebo comparator | Drug: scopolamine HBrPlacebo nasal gel product is the same but does not contain scopolamine HBr |
| Transderm Scop® | Experimental | Drug: Transdermal ScopolamineTDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of signed and dated ICD.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 59 (inclusive).
- Active duty military or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by PI or qualified designee prior to signing the ICD.
- At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
Key exclusion criteria (13 listed)
- Pregnancy, lactation, or positive urine pregnancy test at screening.
- Known allergic reactions to scopolamine or other anticholinergics.
- Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
- Hospitalization or significant surgery requiring hospital admittance within the past six months.
- Treatment with another investigational drug or other intervention within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scopolamine HBrNasal Gel | Drug | DPI-386 nasal gel, placebo nasal gel |
| Transdermal ScopolaminePatch | Drug | Transderm Scop® |
Primary outcome
Efficacy of DPI-386 Nasal Gel
Time frame: 3 days
Compare the efficacy of DPI-386 Nasal Gel (0.2 mg scopolamine HBr per dose, maximum of two doses per day, for a maximum of six doses over three consecutive days) with that of the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ) scores over the treatment period across all three treatment arm. Sixteen symptoms are listed, with symptoms differentiated along four dimensions: gastrointestinal, central, peripheral, and sopite-related. Each symptom is scored from 1 to 9 in severity and scores then calculated. All 16 items were collected from the general public instead of experts, allowing for a more accurate wording of the symptomology experienced by persons outside of hysiological sciences.
Safety of DPI-386 Nasal Gel in terms of cognitive effects
Time frame: 24 hours
Compare the safety of DPI-386 Nasal Gel with that of the TDS patch and placebo nasal gel, with an emphasis on cognitive effects by incidence of treatment related adverse events.
2 secondary outcomes
Efficacy of DPI-386 and severe nausea
Time frame: 3 days
Safety of DPI-386 Nasal Gel in terms of cognition
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Helton study director
Repurposed Therapuetics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing scopolamine HBr and Transdermal Scopolamine in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of DPI-386 Nasal Gel (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.