search
Back to results

Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects

Primary Purpose

Motion Sickness

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Scopolamine
Placebo Nasal Gel
Sponsored by
Repurposed Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness focused on measuring Anticholinergic, Scopolamine

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Provision of a signed and dated Informed Consent Form (ICF).
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female, aged 55 and over.
  4. 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.
  5. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.

  6. 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.

Exclusion Criteria:

  1. Known allergic reactions to scopolamine or other anticholinergics.

  2. 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),
    • muscle relaxants (washout 4 days) and
    • nasal decongestants (washout 4 days)
  3. Hospitalization or significant surgery requiring hospital admittance within the past six months.
  4. Treatment with another investigational drug or other intervention within the past 30 days.
  5. Having donated blood or plasma or suffered significant blood loss within the past 30 days.

  6. 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.

Sites / Locations

  • Collaborative Neuroscience Network, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DPI-386 Nasal Gel

Placebo Nasal Gel

Arm Description

DPI-386 Nasal Gel (0.2 mg / 0.12 g)

placebo nasal gel (0.12 g)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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)
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).
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)

Full Information

First Posted
June 6, 2019
Last Updated
May 3, 2023
Sponsor
Repurposed Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03988530
Brief Title
Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repurposed Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
Keywords
Anticholinergic, Scopolamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
This study is double-blinded placebo controlled for all treatment arms on Treatment Day 1. All DPI-386 Nasal Gel and placebo nasal gel vials are opaque and indistinguishable. The DPI-386 Nasal Gel and placebo nasal gels are identical in color and viscosity, and without identifiable smell. Treatment Days 2-4 are open-label.
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPI-386 Nasal Gel
Arm Type
Active Comparator
Arm Description
DPI-386 Nasal Gel (0.2 mg / 0.12 g)
Arm Title
Placebo Nasal Gel
Arm Type
Placebo Comparator
Arm Description
placebo nasal gel (0.12 g)
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Other Intervention Name(s)
DPI-386 Nasal Gel
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo Nasal Gel
Intervention Description
Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.
Primary Outcome Measure Information:
Title
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
Description
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.
Time Frame
During voyage on Treatment Day 1.
Title
Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.
Description
Safety endpoint is the incidence of adverse events.
Time Frame
During all four Treatment Days
Secondary Outcome Measure Information:
Title
Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period.
Description
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).
Time Frame
During Treatment Day 1 voyage.
Title
Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT).
Description
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).
Time Frame
During Treatment Day 1 voyage
Title
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
Description
PK parameters to be measured by Maximum Observed Plasma Concentration (Cmax)
Time Frame
At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
Title
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
Description
PK parameters to be measured by Time to Reach Maximum Observed Plasma Concentration (Tmax).
Time Frame
At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.
Title
Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.
Description
PK parameters to be measured by Area Under the Curve (AUC)
Time Frame
At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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), 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Helton
Organizational Affiliation
Repurposed Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Publication

Learn more about this trial

Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects

We'll reach out to this number within 24 hrs