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Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness

Primary Purpose

Motion Sickness

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
scopolamine HBr
Transdermal Scopolamine
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 signed and dated ICD.
  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. Active duty military or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by PI or qualified designee prior to signing the ICD.
  5. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
  6. In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as recommended by the PI or qualified designee.
  7. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
  8. For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. Test must be negative.

  9. Agreement to adhere to the following lifestyle compliance considerations:

    1. 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.
    2. Abstain from alcohol for 24 hours prior to first dose of study medication and during the six Treatment Days.

Exclusion Criteria:

  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, and muscle relaxants.
  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 deemed clinically significant by the PI or qualified designee as being exclusionary:

    1. Significant gastrointestinal disorder, asthma, or seizure disorders.
    2. History of vestibular disorders.
    3. History of narrow-angle glaucoma.
    4. History of urinary retention problems.
    5. History of alcohol or drug abuse.
    6. Nasal, nasal sinus, or nasal mucosa surgery.

Sites / Locations

  • NAMRU-DRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

DPI-386 nasal gel

placebo nasal gel

Transderm Scop®

Arm Description

DPI-386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.1 g dose, with each dose therefore described as "0.2 mg / 0.1 g"

Placebo nasal gel product is the same but does not contain scopolamine HBr

TDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days.

Outcomes

Primary Outcome Measures

Efficacy of DPI-386 Nasal Gel
Compare the efficacy of DPI-386 Nasal Gel (0.2 mg scopolamine HBr per dose, maximum of two doses per day, for a maximum of six doses over three consecutive days) with that of the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ) scores over the treatment period across all three treatment arm. 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 hysiological sciences.
Safety of DPI-386 Nasal Gel in terms of cognitive effects
Compare the safety of DPI-386 Nasal Gel with that of the TDS patch and placebo nasal gel, with an emphasis on cognitive effects by incidence of treatment related adverse events.

Secondary Outcome Measures

Efficacy of DPI-386 and severe nausea
Compare the efficacies of DPI-386 Nasal Gel, TDS patch, and placebo nasal gel in severity of nausea. Respondents specify their degree of nausea by indicating a point along a continuous 100mm 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. Severity of nausea will measured by the Nausea Assessment (Visual Analog Scale) (VAS)) over the treatment period.
Safety of DPI-386 Nasal Gel in terms of cognition
Compare the safety of DPI-386 Nasal Gel with that of TDS patch and placebo nasal gel in terms of cognition as measured by the Psychomotor Vigilance Tests (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.

Full Information

First Posted
December 14, 2018
Last Updated
February 13, 2020
Sponsor
Repurposed Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04272255
Brief Title
Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

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

5. Study Description

Brief Summary
This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled and open label active-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 motion sickness. The study will be conducted aboard Navy fleet or Marine ships undergoing military operations to obtain data in an operationally relevant real world environment.
Detailed Description
The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.5 mg/72 hours; transdermal scopolamine patch [TDS], 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 ships and ships' crews will be used, until the required enrollment is completed. The DPI-386 Nasal Gel and placebo nasal gel arms will be double-blinded, whereas the TDS arm will remain unblinded. Both DPI-386 Nasal Gel and placebo nasal gel will be administered twice daily over the six consecutive Treatment Days. The two daily doses of DPI-386 Nasal Gel or placebo nasal gel will be separated by a minimum of six hours ± 15 minutes, and will occur during the subject's on-duty period. The TDS patch will be administered on Treatment Days 1 and 4.

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
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPI-386 nasal gel
Arm Type
Active Comparator
Arm Description
DPI-386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.1 g dose, with each dose therefore described as "0.2 mg / 0.1 g"
Arm Title
placebo nasal gel
Arm Type
Placebo Comparator
Arm Description
Placebo nasal gel product is the same but does not contain scopolamine HBr
Arm Title
Transderm Scop®
Arm Type
Experimental
Arm Description
TDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days.
Intervention Type
Drug
Intervention Name(s)
scopolamine HBr
Intervention Description
Nasal Gel
Intervention Type
Drug
Intervention Name(s)
Transdermal Scopolamine
Intervention Description
Patch
Primary Outcome Measure Information:
Title
Efficacy of DPI-386 Nasal Gel
Description
Compare the efficacy of DPI-386 Nasal Gel (0.2 mg scopolamine HBr per dose, maximum of two doses per day, for a maximum of six doses over three consecutive days) with that of the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ) scores over the treatment period across all three treatment arm. 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 hysiological sciences.
Time Frame
3 days
Title
Safety of DPI-386 Nasal Gel in terms of cognitive effects
Description
Compare the safety of DPI-386 Nasal Gel with that of the TDS patch and placebo nasal gel, with an emphasis on cognitive effects by incidence of treatment related adverse events.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Efficacy of DPI-386 and severe nausea
Description
Compare the efficacies of DPI-386 Nasal Gel, TDS patch, and placebo nasal gel in severity of nausea. Respondents specify their degree of nausea by indicating a point along a continuous 100mm 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. Severity of nausea will measured by the Nausea Assessment (Visual Analog Scale) (VAS)) over the treatment period.
Time Frame
3 days
Title
Safety of DPI-386 Nasal Gel in terms of cognition
Description
Compare the safety of DPI-386 Nasal Gel with that of TDS patch and placebo nasal gel in terms of cognition as measured by the Psychomotor Vigilance Tests (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.
Time Frame
24 hours

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 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 or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by 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 as recommended by the 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. Test must be negative. 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 six treatment days. Abstain from alcohol for 24 hours prior to first dose of study medication and during the six Treatment Days. Exclusion Criteria: Pregnancy, lactation, or positive urine pregnancy test at screening. Known allergic reactions to scopolamine or other anticholinergics. Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants. 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 deemed clinically significant by the PI or qualified designee as being exclusionary: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Helton
Organizational Affiliation
Repurposed Therapuetics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
NAMRU-D
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Doubravo, MD
Phone
937-938-3915
Email
matthew.doubravo@us.af.mil

12. IPD Sharing Statement

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Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness

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