Motion SicknessPhase 2/3NCT04219982
DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness
A Phase 2/3 study testing DPI-386 Nasal Gel and Transderm Scop® in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial summary
Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the… 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 and Transderm Scop®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to 28 Jan 2019
- Phase
- Phase 2/3
- 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, reserves on active status, or dependents covered by Tricare health insurance. All potential subjects must be able to provide a current military or DoD dependent ID to be viewed by the 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 that would affect rotation in a vestibular study (e.g., vestibular pathology, seizure disorder, sinus congestion), as assessed by the PI or qualified designee.
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- Laboratory test results that are determined by the PI or qualified designee to be normal or - if slightly out of the normal range - determined to be not clinically significant. The following laboratory tests will be performed:
- Hematology panel (WBC, RBC, HGB, Hct)
- Biochemistry panel (liver function: bilirubin [total and direct], ALT, AST, ALP, and GGT; Albumin, Creatinine, BUN, and Cortisol)
- Electrolytes (Na+, K+, Cl-, Ca2+, and PO4)
- 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 upon every visit to NAMRU-D. Test must be negative.
- Agreement to adhere to the following lifestyle 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.
- Caffeine intake limited to 900 mg per day (six 8-ounce cups per day [daily total of 1.4 liters]) during the six treatment days.
- Abstain from alcohol for 24 hours prior to first dose of study medication and during the six treatment days.
- Cigarettes limited to no more than one pack per day; cigars to one per day; and chewing tobacco to no more than a quarter of a can per day during the six treatment days.
Who cannot join
- 1. Pregnancy, lactation, or positive urine pregnancy test at screening.
- 2. Known allergic reactions to scopolamine or other anticholinergics.
- 3. Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, muscle relaxants and nasal decongestants.
- 4. Hospitalization or significant surgery requiring hospital admittance within the past six months.
- 5. Treatment with another investigational drug or other intervention within the past 30 days.
- 6. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
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- 7. Use of a nicotine patch. 8. 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.
- History of alcohol or drug abuse.
- Nasal, nasal sinus, or nasal mucosa surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study of the Safety, Pharmacokinetics, and Efficacy of DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness
Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.
Read the detailed description
Each subject eligible for the study on Day 0 will be assigned a subject number (starting with 101 for male subjects and 201 for female subjects) in consecutive order which will randomize the subject to one of the three study arms: double-blind DPI-386 Nasal Gel; double-blind placebo nasal gel; or Transderm Scop® (TDS). The subject number will link the nasal gel (active or placebo) treatment arms (double-blind) to a multi digit random number (study drug kit number) different from the subject number. The nasal gel vials, contained in the study drug kit, will be labelled with the same study drug kit number. 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.
- Conditions
- Motion Sickness
- Being tested
- DPI-386 Nasal Gel, DPI-386 Placebo Nasal Gel, Transderm Scop®
- 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
Nasal gel
DPI-386 Placebo Nasal GelDrug
DPI-386 Placebo Nasal Gel
Transderm Scop®Drug
Transderm Scop®
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 Nasal Gel | Experimental | Active DPI-386 Nasal Gel Receives: Drug: DPI-386 Nasal Gel |
| DPI-386 Placebo Nasal Gel | Placebo comparator | Placebo Nasal Gel Receives: Drug: DPI-386 Placebo Nasal Gel |
| Transderm Scop® (TDS) | Active comparator | FDA approved Transderm Scop® (TDS). Receives: Drug: Transderm Scop® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of time spent in mechanical rotation until nausea (inclination to vomit) is achieved, or 20 minutes have elapsed.
Measured: up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start29 Jun 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Why it stopped: Failure to meet enrollment
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The sample size of 54 allows for an equal distribution of subjects within gender and treatment arm: 18 subjects per treatment arm with 9 per gender.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Helton, Study director, Repurposed Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219982
- Sponsor's protocol ID
- DPI-386-07
- Status last verified
- Jan 2020
- First submitted
- 11 Mar 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 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, Pharmacokinetics, and Efficacy of DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness
- ClinicalTrials.gov ID
- NCT04219982
- Acronym / sponsor ID
- DPI-386-07
- Conditions
- Motion Sickness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to meet enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 7 Jan 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.
Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.
Detailed description
Each subject eligible for the study on Day 0 will be assigned a subject number (starting with 101 for male subjects and 201 for female subjects) in consecutive order which will randomize the subject to one of the three study arms: double-blind DPI-386 Nasal Gel; double-blind placebo nasal gel; or Transderm Scop® (TDS). The subject number will link the nasal gel (active or placebo) treatment arms (double-blind) to a multi digit random number (study drug kit number) different from the subject number. The nasal gel vials, contained in the study drug kit, will be labelled with the same study drug kit number. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The sample size of 54 allows for an equal distribution of subjects within gender and treatment arm: 18 subjects per treatment arm with 9 per gender.
| Arm | Type | Receives |
|---|---|---|
| DPI-386 Nasal Gel | Experimental | Drug: DPI-386 Nasal GelActive DPI-386 Nasal Gel |
| DPI-386 Placebo Nasal Gel | Placebo comparator | Drug: DPI-386 Placebo Nasal GelPlacebo Nasal Gel |
| Transderm Scop® (TDS) | Active comparator | Drug: Transderm Scop®FDA approved Transderm Scop® (TDS). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 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, reserves on active status, or dependents covered by Tricare health insurance. All potential subjects must be able to provide a current military or DoD dependent ID to be viewed by the 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)
- 1. Pregnancy, lactation, or positive urine pregnancy test at screening.
- 2. Known allergic reactions to scopolamine or other anticholinergics.
- 3. Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, muscle relaxants and nasal decongestants.
- 4. Hospitalization or significant surgery requiring hospital admittance within the past six months.
- 5. 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 GelNasal gel | Drug | DPI-386 Nasal Gel |
| DPI-386 Placebo Nasal GelDPI-386 Placebo Nasal Gel | Drug | DPI-386 Placebo Nasal Gel |
| Transderm Scop®Transderm Scop® | Drug | Transderm Scop® (TDS) |
Primary outcome
The length of time spent in mechanical rotation until nausea (inclination to vomit) is achieved, or 20 minutes have elapsed.
Time frame: up to 20 minutes
Results and safety
The study was stopped early (reason given: Failure to meet enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 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 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 2/3 study testing DPI-386 Nasal Gel and Transderm Scop® 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 17 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: stopped early, as of the sponsor's last update on 7 Jan 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Failure to meet enrollment). Results are not available in the source record.
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 length of time spent in mechanical rotation until nausea (inclination to vomit) is achieved, or 20 minutes have elapsed. (time frame: up to 20 minutes). 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 7 Jan 2020.