search
Back to results

Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness

Primary Purpose

Motion Sickness

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DPI-386 Nasal Gel
Placebos
Sponsored by
Repurposed Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness

Eligibility Criteria

18 Years - 59 Years (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 18 to 59 (inclusive).
  4. At least two responses on the MSSQ must be "Sometimes" or "Frequently".
  5. 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.
  6. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
  7. 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.

  8. 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. Pregnancy, lactation, or positive urine pregnancy test within seven days of Treatment Day 1.
  2. Known allergic reactions to scopolamine or other anticholinergics.

  3. 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)
  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.

  7. 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 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

DPI-386 Nasal Gel + placebo patch

Placebo nasal gel + Placebo patch

placebo nasal gel + TDS patch

Arm Description

DPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr

Placebo

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.

Outcomes

Primary Outcome Measures

Incidence of subjects who developed motion sickness.
Number of Subjects who developed motion sickness
Adverse Event (AE) Reporting of DPI-386
Number of subjects with indicated AEs receiving DPI-386

Secondary Outcome Measures

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).
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).
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).
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.
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.
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.

Full Information

First Posted
June 6, 2019
Last Updated
December 2, 2019
Sponsor
Repurposed Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04184115
Brief Title
Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 9, 2019 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 11, 2019 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
study is double-blinded placebo controlled for all treatment arms. 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. Each placebo patch is similar in color and size as the TDS patch but does not deliver any medication or contain any excipients. A designated independent (unblinded) applicator will administer all patch application and removal, including an opaque waterproof bandage cover over the patch, to further prevent unblinding.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPI-386 Nasal Gel + placebo patch
Arm Type
Experimental
Arm Description
DPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr
Arm Title
Placebo nasal gel + Placebo patch
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
placebo nasal gel + TDS patch
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DPI-386 Nasal Gel
Other Intervention Name(s)
Transderm Scop®
Intervention Description
1.5 mg reservoir of scopolamine to be delivered over a 72-hour period
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo Nasal Gel and placebo patch
Primary Outcome Measure Information:
Title
Incidence of subjects who developed motion sickness.
Description
Number of Subjects who developed motion sickness
Time Frame
8 hours
Title
Adverse Event (AE) Reporting of DPI-386
Description
Number of subjects with indicated AEs receiving DPI-386
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Severity of nausea as measured by the Visual Analog Scale (VAS)
Description
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).
Time Frame
During the 8 hour voyage on Treatment Day 1.
Title
Severity of motion sickness as measured by the Motion Sickness Assessment Questionnaire (MSAQ) over the treatment period.
Description
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).
Time Frame
During the 8 hour voyage on Treatment Day 1.
Title
3. Cognition as measured by the Automated Neuropsychological Assessment Metrics (ANAM).
Description
This battery consists of the ANAM CORE battery plus the Running Memory Continuous Performance Test (CPT).
Time Frame
During all three Treatment Days.
Title
Pharmacokinetic parameters of DPI-386 to be measured will include Maximum Observed Plasma Concentrations (Cmax)
Description
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.
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.
Title
Pharmacokinetic parameters of DPI-386 to be measured will include Time to Reach Maximum Observed Plasma Concentration (tmax).
Description
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.
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.
Title
Pharmacokinetic parameters of DPI-386 to be measured will include Area Under the Curve (AUC).
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 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 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. 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. Exclusion Criteria: 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), 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

Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness

We'll reach out to this number within 24 hrs