Recruiting
Phase 3

Nasal Gel

Sponsor:

Repurposed Therapeutics, Inc.

Code:

NCT04272255

Conditions

Motion Sickness

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

scopolamine HBr

Transdermal Scopolamine

Study Details

Brief summary:

This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled and open label active-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 motion sickness. The study will be conducted aboard Navy fleet or Marine ships undergoing military operations to obtain data in an operationally relevant real world environment.

Conditions

Motion Sickness

Study ID

NCT04272255

Start date

Apr 22, 2019

Status verified date

Feb, 2020

Completion date

Jul, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Provision of signed and dated ICD.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18 to 59 (inclusive).
4. Active duty military or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by PI or qualified designee prior to signing the ICD.
5. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
6. In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as recommended by the PI or qualified designee.
7. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
8. For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. Test must be negative.
9. Agreement to adhere to the following lifestyle compliance considerations:

1. Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the six treatment days.
2. Abstain from alcohol for 24 hours prior to first dose of study medication and during the six Treatment Days.

Exclusion Criteria:

1. Pregnancy, lactation, or positive urine pregnancy test at screening.
2. Known allergic reactions to scopolamine or other anticholinergics.
3. Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
4. Hospitalization or significant surgery requiring hospital admittance within the past six months.
5. Treatment with another investigational drug or other intervention within the past 30 days.
6. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
7. Having any of the following medical conditions within the last two years or deemed clinically significant by the PI or qualified designee as being exclusionary:

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DPI-386 nasal gel

DPI-386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.1 g dose, with each dose therefore described as "0.2 mg / 0.1 g"

placebo comparator: placebo nasal gel

Placebo nasal gel product is the same but does not contain scopolamine HBr

experimental: Transderm Scop®

TDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days.

Interventions

scopolamine HBr

Nasal Gel

Transdermal Scopolamine

Patch

Primary outcome measure

  • Efficacy of DPI-386 Nasal Gel [ Time Frame: 3 days ]
  • Safety of DPI-386 Nasal Gel in terms of cognitive effects [ Time Frame: 24 hours ]

Central Contacts and Locations

Locations

NAMRU-D

Recruiting

Dayton, Ohio, United States, 45433

Contacts

More Information

Sponsor

Repurposed Therapeutics, Inc.

Last update posted

Feb 17, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Repurposed Therapeutics, Inc. on 2020-02-17.