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
Overview
- Phase
- Phase 3
- Intervention
- Scopolamine
- Conditions
- Motion Sickness
- Sponsor
- Repurposed Therapeutics, Inc.
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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 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.
Exclusion Criteria
- •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.
Arms & Interventions
DPI-386 Nasal Gel
DPI-386 Nasal Gel (0.2 mg / 0.12 g)
Intervention: Scopolamine
Placebo Nasal Gel
placebo nasal gel (0.12 g)
Intervention: Placebo Nasal Gel
Outcomes
Primary Outcomes
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
Time Frame: During voyage on Treatment Day 1.
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.
Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.
Time Frame: During all four Treatment Days
Safety endpoint is the incidence of adverse events.
Secondary Outcomes
- Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period.(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.)
- Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT).(During Treatment Day 1 voyage)