The Prevention and Treatment of Nausea Associated With Motion Sickness

NCT03986905 | Completed Phase 3 FDA Drug

• 1 other identifier: DPI-386-MS-21
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (1)

• 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.

  During three consecutive days

Study Arms (3)

Scopolamine Nasal Gel

EXPERIMENTAL

DPI-386 Nasal Gel + placebo patch

Drug: Scopolamine Nasal Gel; Other: Placebo

Placebo

PLACEBO COMPARATOR

placebo nasal gel + placebo patch

Other: Placebo

TDS Patch

ACTIVE COMPARATOR

placebo nasal gel + TDS patch

Drug: Scopolamine Nasal Gel; Other: Placebo

Interventions

Scopolamine Nasal Gel DRUG

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.

Also known as: Scopolamine Patch

Scopolamine Nasal Gel; TDS Patch

Placebo OTHER

placebo nasal gel + placebo patch

Also known as: Placebo Patch and Placebo Nasal Gel

Placebo; Scopolamine Nasal Gel; TDS Patch

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead

Study Sites (1)

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dave Helton

  Repurposed Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: April 26, 2019
• Primary Completion: May 19, 2019
• Study Completion: June 19, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)