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

NCT ID: NCT03988530

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-07
• Study Completion Date: 2020-11-23

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

Detailed Description

This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study with open-label follow-up 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 two arms: DPI-386 nasal gel and placebo nasal gel for Treatment Day 1. Treatment Day 1 will include 50 subjects per arm, for a total of 100 subjects (n=100). All 100 subjects from Treatment Day 1 will receive open-label DPI-386 Nasal Gel for Treatment Days 2-4 (50 of these were originally randomized to receive placebo prior to receipt of the investigational product.).

Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment and within 30 days of Treatment Day 1, Treatment Days 2-4 will take place at the clinical site.

Conditions

Motion Sickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DPI-386 Nasal Gel

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

Group Type: ACTIVE_COMPARATOR

Scopolamine

Intervention Type: 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).

Placebo Nasal Gel

placebo nasal gel (0.12 g)

Group Type: PLACEBO_COMPARATOR

Placebo Nasal Gel

Intervention Type: OTHER

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

Interventions

Scopolamine

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).

Intervention Type: DRUG

Placebo Nasal Gel

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

Intervention Type: OTHER

Other Intervention Names

DPI-386 Nasal Gel

Eligibility Criteria

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 55 and over.

4. 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.

5. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.

6. 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. Known allergic reactions to scopolamine or other anticholinergics.

2. 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)

3. Hospitalization or significant surgery requiring hospital admittance within the past six months.

4. Treatment with another investigational drug or other intervention within the past 30 days.

5. Having donated blood or plasma or suffered significant blood loss within the past 30 days.

6. 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Repurposed Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Helton

Role: STUDY_DIRECTOR

Repurposed Therapeutics, Inc.

Locations

Collaborative Neuroscience Network, LLC

Long Beach, California, United States

Countries

United States

Other Identifiers

DPI-386-MS-24

Identifier Type: -

Identifier Source: org_study_id