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

NCT03988530 | Completed Phase 3 FDA Drug

• 1 other identifier: DPI-386-MS-24
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Conditions

Motion Sickness

Keywords

Anticholinergic; Scopolamine

Outcome Measures

Primary Outcomes (2)

• 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.

  During 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.

  During all four Treatment Days

Secondary Outcomes (5)

• Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period.

  During Treatment Day 1 voyage.

• Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT).

  During Treatment Day 1 voyage

• Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.

  At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.

• Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.

  At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.

• Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel.

  At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4.

Study Arms (2)

DPI-386 Nasal Gel

ACTIVE COMPARATOR

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

Drug: Scopolamine

Placebo Nasal Gel

PLACEBO COMPARATOR

placebo nasal gel (0.12 g)

Other: Placebo Nasal Gel

Interventions

Scopolamine DRUG

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).

Also known as: DPI-386 Nasal Gel

DPI-386 Nasal Gel

Placebo Nasal Gel OTHER

Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.

Placebo Nasal Gel

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

You may not qualify if:

• 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.

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

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• David R 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: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 17, 2019
• Study Start: June 7, 2019
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)