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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
Scopolamine Nasal Gel
Placebo
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:

  • 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 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 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 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:

    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

  • Collaborative Neuroscience Network, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Scopolamine Nasal Gel

Placebo

TDS Patch

Arm Description

DPI-386 Nasal Gel + placebo patch

placebo nasal gel + placebo patch

placebo nasal gel + TDS patch

Outcomes

Primary Outcome Measures

The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2019
Last Updated
December 2, 2019
Sponsor
Repurposed Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03986905
Brief Title
The Prevention and Treatment 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 on Ocean Going Vessels 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
April 26, 2019 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
June 19, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-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 nausea associated with motion sickness. The study will be conducted aboard an ocean going vessel to obtain data in a real world environment. 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 100 subjects per arm, for a total of 300 subjects (n=300). Multiple voyages with the same vessel will be used until the required enrollment is completed. 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, and placebo nasal gel + TDS patch.
Detailed Description
The investigational product will be administered using a delivery device comprised of: (a) a vial prefilled with DPI-386 Nasal Gel or placebo nasal gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. 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. The DPI 386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". The placebo nasal gel product is the same but does not contain scopolamine HBr. Each vial of DPI 386 Nasal Gel or placebo nasal gel is a multi-dose product, sufficient for three days of dosing (two doses per day). Each pumping action is designed to deliver a single 0.12 g dose. Each vial/delivery device must be primed by the subject prior to first dose delivery for that vial. Each time a new bottle is used, it needs to be initially primed with 5 actuations. The 6th actuation is the first dose and subsequent actuations are doses 2-6 of that bottle. No re-priming is needed at all. Subjects will be trained in priming by research staff, and all priming will be performed under supervision by the research staff. All subjects will self-administer the nasal gel twice daily over the three day treatment period, with no more than two doses every 24 hours, unless a third dose is deemed necessary by the PI or qualified designee, and the two daily doses separated by a minimum of six hours ± 15 minutes

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
A double-dummy design will be used to mask the treatment assignment. A double-dummy design will be used to mask the treatment assignment. 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
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scopolamine Nasal Gel
Arm Type
Experimental
Arm Description
DPI-386 Nasal Gel + placebo patch
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo nasal gel + placebo patch
Arm Title
TDS Patch
Arm Type
Active Comparator
Arm Description
placebo nasal gel + TDS patch
Intervention Type
Drug
Intervention Name(s)
Scopolamine Nasal Gel
Other Intervention Name(s)
Scopolamine Patch
Intervention Description
All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Patch and Placebo Nasal Gel
Intervention Description
placebo nasal gel + placebo patch
Primary Outcome Measure Information:
Title
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage
Description
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.
Time Frame
During three consecutive days

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 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 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 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 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
Dave 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
In publication and CSR.

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The Prevention and Treatment of Nausea Associated With Motion Sickness

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