Motion SicknessPhase 3NCT03988530
Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects
A Phase 3 study testing Scopolamine in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Scopolamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 23 Nov 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 55 and over.
- 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.
- 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
- 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),
- tricyclic antidepressants (washout 2 weeks),
Show all 19Show fewer
- 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 in Senior Subjects With Open-Label Follow-Up
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
Read the detailed description
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.
- Conditions
- Motion Sickness
- Being tested
- Scopolamine, Placebo Nasal Gel
- Keywords
- Anticholinergic, 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.
ScopolamineDrug
Also called DPI-386 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).
Placebo Nasal GelOther
Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 Nasal Gel | Active comparator | DPI-386 Nasal Gel (0.2 mg / 0.12 g) Receives: Drug: Scopolamine |
| Placebo Nasal Gel | Placebo comparator | placebo nasal gel (0.12 g) Receives: Other: Placebo Nasal Gel |
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 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.
Measured: 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.
Measured: During all four Treatment Days
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start7 Jun 2019
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
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
- 98 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
- NCT03988530
- Sponsor's protocol ID
- DPI-386-MS-24
- Status last verified
- May 2023
- First submitted
- 6 Jun 2019
- Last updated
- 6 May 2023
- 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 6 May 2023. 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 in Senior Subjects With Open-Label Follow-Up
- ClinicalTrials.gov ID
- NCT03988530
- Acronym / sponsor ID
- DPI-386-MS-24
- Conditions
- Motion Sickness
- Keywords
- Anticholinergic, Scopolamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 17 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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPI-386 Nasal Gel | Active comparator | Drug: ScopolamineDPI-386 Nasal Gel (0.2 mg / 0.12 g) |
| Placebo Nasal Gel | Placebo comparator | Other: Placebo Nasal Gelplacebo nasal gel (0.12 g) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 55 and over.
- 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.
Key exclusion criteria (19 listed)
- 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.
- Having donated blood or plasma or suffered significant blood loss 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 |
|---|---|---|
| ScopolamineAlso: DPI-386 Nasal GelSubjects 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). | Drug | DPI-386 Nasal Gel |
| Placebo Nasal GelPlacebo Nasal Gel (0.12g) twice a day on Treatment Day 1. | Other | Placebo Nasal Gel |
Primary outcome
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
Time frame: During voyage 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) during an 8 hour voyage on Treatment Day 1.
Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.
Time frame: During all four Treatment Days
Safety endpoint is the incidence of adverse events.
5 secondary outcomes
Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period.
Time frame: During Treatment Day 1 voyage.
Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT).
Time frame: During Treatment Day 1 voyage
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
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.
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.
Time frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
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 6 May 2023.
- 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 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 8 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 6 May 2023. 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 requested further treatment (i.e., subjects who received rescue medication). (time frame: During voyage on Treatment Day 1.). 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 6 May 2023.