Motion SicknessPhase 3NCT04184115
Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness
A Phase 3 study testing DPI-386 Nasal Gel in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial summary
Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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. 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?
- DPI-386 Nasal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2019to 11 Jun 2019
- 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 a signed and dated Informed Consent Form (ICF).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 59 (inclusive).
- At least two responses on the MSSQ must be "Sometimes" or "Frequently".
- In good general health as evidenced by medical history with no recent history or current diagnosis of uncontrolled clinical problems as assessed by the Principal Investigator (PI) or qualified designee.
- Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
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- For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. The test must be negative within seven days of the Treatment Day 1.
- 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 three Treatment Days.
- Abstain from alcohol for 24 hours prior to first dose of study medication and during the three Treatment Days.
Who cannot join
- Pregnancy, lactation, or positive urine pregnancy test within seven days of Treatment Day 1.
- Known allergic reactions to scopolamine or other anticholinergics.
- Currently prescribed any of the following medication types and used within the specified washout periods below:
- any form of scopolamine (including Transderm Scop®) (washout 5 days)
- belladonna alkaloids (washout 2 weeks),
- antihistamines (including meclizine) (washout 2 weeks),
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- tricyclic antidepressants (washout 2 weeks),
- muscle relaxants (washout 4 days) and
- nasal decongestants (washout 4 days)
- 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.
- 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 clinically significant by the PI or qualified designee:
- Significant gastrointestinal disorder, asthma, or seizure disorders.
- History of cardiovascular disease.
- 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
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
About this study
Official title: 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
Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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.
Read the detailed description
This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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 three arms: DPI-386 nasal gel, placebo nasal gel, and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion sickness. The study will include 34 subjects per arm, for a total of 102 subjects (n=102). A double dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel randomized to one of the following three arms: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment immediately followed by Treatment Days 2 and 3 at a clinical site or one of its two satellite locations.
- Conditions
- Motion Sickness
- Being tested
- DPI-386 Nasal Gel, Placebos
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPI-386 Nasal GelDrug
Also called Transderm Scop®
1.5 mg reservoir of scopolamine to be delivered over a 72-hour period
PlacebosDrug
Placebo Nasal Gel and placebo patch
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 Nasal Gel + placebo patch | Experimental | DPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr Receives: Drug: DPI-386 Nasal Gel; Drug: Placebos |
| Placebo nasal gel + Placebo patch | Placebo comparator | Placebo Receives: Drug: Placebos |
| placebo nasal gel + TDS patch | Active comparator | Transderm Scop® is a commercial transdermal scopolamine (TDS) patch worn behind the ear containing a 1.5 mg reservoir of scopolamine to be delivered over a 72-hour period. Receives: Drug: DPI-386 Nasal Gel; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects who developed motion sickness.
Number of Subjects who developed motion sickness
Measured: 8 hours
Adverse Event (AE) Reporting of DPI-386
Number of subjects with indicated AEs receiving DPI-386
Measured: 7 weeks
Secondary outcomes (6)
Severity of nausea as measured by the Visual Analog Scale (VAS)
VAS - 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).
Measured: During the 8 hour voyage on Treatment Day 1.
Severity of motion sickness as measured by the Motion Sickness Assessment Questionnaire (MSAQ) over the treatment period.
MSAQ - The MSAQ was designed to measure motion sickness as a multi-dimensional construct, with the understanding that when an individual states they are experiencing motion sickness, it is unlikely a single symptom, but rather a complex set of symptoms, with varying levels of severity. 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 physiological sciences. The MSAQ has been repeatedly validated and is strongly correlated with both the Pensacola Diagnostic index (r = 0.81, p < 0.001) and the Nausea Profile (r = 0.92, p < 0.001).
Measured: During the 8 hour voyage on Treatment Day 1.
3. Cognition as measured by the Automated Neuropsychological Assessment Metrics (ANAM).
This battery consists of the ANAM CORE battery plus the Running Memory Continuous Performance Test (CPT).
Measured: During all three Treatment Days.
Pharmacokinetic parameters of DPI-386 to be measured will include Maximum Observed Plasma Concentrations (Cmax)
Pharmacokinetics will be assessed by the amount of total free scopolamine at each time point blood is collected and plasma samples will be assayed for scopolamine using a fully validated LC/MS method.
Measured: On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Pharmacokinetic parameters of DPI-386 to be measured will include Time to Reach Maximum Observed Plasma Concentration (tmax).
Pharmacokinetics will be assessed by the amount of total free scopolamine at each time point blood is collected and plasma samples will be assayed for scopolamine using a fully validated LC/MS method.
Measured: On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Pharmacokinetic parameters of DPI-386 to be measured will include Area Under the Curve (AUC).
Pharmacokinetics will be assessed by the amount of total free scopolamine at each time point blood is collected and plasma samples will be assayed for scopolamine using a fully validated LC/MS method.
Measured: On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start9 Jun 2019
- Primary completion11 Jun 2019
- Study completion11 Jun 2019
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Helton, Study director, Repurposed Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184115
- Sponsor's protocol ID
- DPI-386-MS-22
- Status last verified
- Dec 2019
- First submitted
- 6 Jun 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. 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, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness
- ClinicalTrials.gov ID
- NCT04184115
- Acronym / sponsor ID
- DPI-386-MS-22
- Conditions
- Motion Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2019 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 3 Dec 2019 (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.
Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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.
Detailed description
This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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 three arms: DPI-386 nasal gel, placebo nasal gel, and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion sickness. The study will include 34 subjects per arm, for a total of 102 subjects (n=102). A double dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel randomized to one of the following three arms: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment immediately followed by Treatment Days 2 and 3 at a clinical site or one of its two satellite locations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DPI-386 Nasal Gel + placebo patch | Experimental | Drug: DPI-386 Nasal Gel, Drug: PlacebosDPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr |
| Placebo nasal gel + Placebo patch | Placebo comparator | Drug: PlacebosPlacebo |
| placebo nasal gel + TDS patch | Active comparator | Drug: DPI-386 Nasal Gel, Drug: PlacebosTransderm Scop® is a commercial transdermal scopolamine (TDS) patch worn behind the ear containing a 1.5 mg reservoir of scopolamine to be delivered over a 72-hour period. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provision of a signed and dated Informed Consent Form (ICF).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 59 (inclusive).
- At least two responses on the MSSQ must be "Sometimes" or "Frequently".
- In good general health as evidenced by medical history with no recent history or current diagnosis of uncontrolled clinical problems as assessed by the Principal Investigator (PI) or qualified designee.
Key exclusion criteria (20 listed)
- Pregnancy, lactation, or positive urine pregnancy test within seven days of Treatment Day 1.
- Known allergic reactions to scopolamine or other anticholinergics.
- Currently prescribed any of the following medication types and used within the specified washout periods below:
- 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 |
|---|---|---|
| DPI-386 Nasal GelAlso: Transderm Scop®1.5 mg reservoir of scopolamine to be delivered over a 72-hour period | Drug | DPI-386 Nasal Gel + placebo patch, placebo nasal gel + TDS patch |
| PlacebosPlacebo Nasal Gel and placebo patch | Drug | DPI-386 Nasal Gel + placebo patch, Placebo nasal gel + Placebo patch, placebo nasal gel + TDS patch |
Primary outcome
Incidence of subjects who developed motion sickness.
Time frame: 8 hours
Number of Subjects who developed motion sickness
Adverse Event (AE) Reporting of DPI-386
Time frame: 7 weeks
Number of subjects with indicated AEs receiving DPI-386
6 secondary outcomes
Severity of nausea as measured by the Visual Analog Scale (VAS)
Time frame: During the 8 hour voyage on Treatment Day 1.
Severity of motion sickness as measured by the Motion Sickness Assessment Questionnaire (MSAQ) over the treatment period.
Time frame: During the 8 hour voyage on Treatment Day 1.
3. Cognition as measured by the Automated Neuropsychological Assessment Metrics (ANAM).
Time frame: During all three Treatment Days.
Pharmacokinetic parameters of DPI-386 to be measured will include Maximum Observed Plasma Concentrations (Cmax)
Time frame: On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Pharmacokinetic parameters of DPI-386 to be measured will include Time to Reach Maximum Observed Plasma Concentration (tmax).
Time frame: On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Pharmacokinetic parameters of DPI-386 to be measured will include Area Under the Curve (AUC).
Time frame: On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No. Publication
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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 R Helton study director
Repurposed Therapeutics, 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 DPI-386 Nasal Gel 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 3 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of subjects who developed motion sickness. (time frame: 8 hours). 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 3 Dec 2019.