Motion SicknessPhase 3NCT03986905
The Prevention and Treatment of Nausea Associated With Motion Sickness
A Phase 3 study testing Scopolamine Nasal Gel in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial summary
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-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 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?
- Scopolamine Nasal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 19 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 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 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 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 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 and Efficacy of DPI-386 Nasal Gel on Ocean Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-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 nausea associated with motion sickness. The study will be conducted aboard an ocean going vessel to obtain data in a real world environment. 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 100 subjects per arm, for a total of 300 subjects (n=300). Multiple voyages with the same vessel will be used until the required enrollment is completed. 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, and placebo nasal gel + TDS patch.
Read the detailed description
The investigational product will be administered using a delivery device comprised of: (a) a vial prefilled with DPI-386 Nasal Gel or placebo nasal gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. The DPI 386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". The placebo nasal gel product is the same but does not contain scopolamine HBr. Each vial of DPI 386 Nasal Gel or placebo nasal gel is a multi-dose product, sufficient for three days of dosing (two doses per day). Each pumping action is designed to deliver a single 0.12 g dose. Each vial/delivery device must be primed by the subject prior to first dose delivery for that vial. Each time a new bottle is used, it needs to be initially primed with 5 actuations. The 6th actuation is the first dose and subsequent actuations are doses 2-6 of that bottle. No re-priming is needed at all. Subjects will be trained in priming by research staff, and all priming will be performed under supervision by the research staff. All subjects will self-administer the nasal gel twice daily over the three day treatment period, with no more than two doses every 24 hours, unless a third dose is deemed necessary by the PI or qualified designee, and the two daily doses separated by a minimum of six hours ± 15 minutes
- Conditions
- Motion Sickness
- Being tested
- Scopolamine Nasal Gel, Placebo
- 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 Nasal GelDrug
Also called Scopolamine Patch
All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
PlaceboOther
Also called Placebo Patch and Placebo Nasal Gel
placebo nasal gel + placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Scopolamine Nasal Gel | Experimental | DPI-386 Nasal Gel + placebo patch Receives: Drug: Scopolamine Nasal Gel; Other: Placebo |
| Placebo | Placebo comparator | placebo nasal gel + placebo patch Receives: Other: Placebo |
| TDS Patch | Active comparator | placebo nasal gel + TDS patch Receives: Drug: Scopolamine Nasal Gel; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.
Measured: During three consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start26 Apr 2019
- Primary completion19 May 2019
- Study completion19 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Helton, Study director, Repurposed Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986905
- Sponsor's protocol ID
- DPI-386-MS-21
- 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: In publication and CSR.
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 and Efficacy of DPI-386 Nasal Gel on Ocean Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness
- ClinicalTrials.gov ID
- NCT03986905
- Acronym / sponsor ID
- DPI-386-MS-21
- Conditions
- Motion Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 14 Jun 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.
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-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 nausea associated with motion sickness. The study will be conducted aboard an ocean going vessel to obtain data in a real world environment. 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 100 subjects per arm, for a total of 300 subjects (n=300). Multiple voyages with the same vessel will be used until the required enrollment is completed. 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, and placebo nasal gel + TDS patch.
Detailed description
The investigational product will be administered using a delivery device comprised of: (a) a vial prefilled with DPI-386 Nasal Gel or placebo nasal gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. The DPI 386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". The placebo nasal gel product is the same but does not contain scopolamine HBr. Each vial of DPI 386 Nasal Gel or placebo nasal gel is a multi-dose product, sufficient for three days of dosing (two doses per day). Each pumping action is designed to deliver a single 0.12 g dose. Each vial/delivery device must be primed by the subject prior to first dose delivery for that vial. Each time a new bottle is used, it needs to be initially primed with 5 actuations. The 6th actuation is the first dose and subsequent actuations are doses 2-6 of that bottle. No re-priming is needed at all. Subjects will be trained in priming by research staff, and all priming will be performed under supervision by the research staff. All subjects will self-administer the nasal gel twice daily over the three day treatment period, with no more than two doses every 24 hours, unless a third dose is deemed necessary by the PI or qualified designee, and the two daily doses separated by a minimum of six hours ± 15 minutes
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 |
|---|---|---|
| Scopolamine Nasal Gel | Experimental | Drug: Scopolamine Nasal Gel, Other: PlaceboDPI-386 Nasal Gel + placebo patch |
| Placebo | Placebo comparator | Other: Placeboplacebo nasal gel + placebo patch |
| TDS Patch | Active comparator | Drug: Scopolamine Nasal Gel, Other: Placeboplacebo nasal gel + TDS patch |
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 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 uncontrolled clinical problems as assessed by the Principal Investigator (PI) or qualified designee.
Key exclusion criteria (19 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:
- any form of scopolamine (including Transderm Scop®) (washout 5 days)
- belladonna alkaloids (washout 2 weeks),
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 Nasal GelAlso: Scopolamine PatchAll subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch. | Drug | Scopolamine Nasal Gel, TDS Patch |
| PlaceboAlso: Placebo Patch and Placebo Nasal Gelplacebo nasal gel + placebo patch | Other | Placebo, Scopolamine Nasal Gel, TDS Patch |
Primary outcome
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage
Time frame: During three consecutive days
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.
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. In publication and CSR.
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StableEyes With Active Neurofeedback
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OKT With Gaze and Postural Stabilization on Vertigo, MS and QOL in VBH
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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.
Dave 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 Scopolamine 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 19 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?
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage (time frame: During three consecutive days). 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.