Recruiting
Phase 2

Scopolamine & Sensory Augmentation

Sponsor:

Repurposed Therapeutics, Inc.

Code:

NCT05886660

Conditions

Motion Sickness, Space

Motion Sickness

Sea Sickness

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

DPI-386 Nasal Gel

Placebo Nasal Gel

DPI-386 Nasal Gel

Placebo Nasal Gel

Study Details

Brief summary:

The primary specific aim is to evaluate the use of intranasal scopolamine gel and sensory augmentation as an integrated countermeasure to mitigate motion sickness and enhance sensorimotor performance. The proposed intranasal scopolamine gel formulation (Defender Pharmaceuticals, Inc.) offers a safe non-invasive method to self-administer with a rapid onset of action. This study involves a comparison of motion sickness outcome measures when administering intranasal scopolamine gel versus placebo (Aim 1a), and then when administering intranasal scopolamine gel versus placebo with a sensory augmentation belt (Aim 1b).

Conditions

Motion Sickness, Space

Motion Sickness

Sea Sickness

Study ID

NCT05886660

Start date

Jan 21, 2022

Status verified date

May, 2024

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Subjects should be minimally susceptible to provocative motion as evidenced by at least two responses on the Motion Sickness Susceptibility Questionnaire of "Sometimes" or "Frequently."
2. No participants should have neurologic, vestibular or autonomic disorders, or medical conditions that could be worsened by scopolamine (narrow-angle glaucoma or urinary retention
3. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test < 7 days prior to study drug administration or no COVID 19 symptoms up to 10 days prior to study drug administration.

Exclusion Criteria:

1. Subjects will be excluded if they are taking other drugs that are capable of causing CNS effects such as antihistamines, tricyclic antidepressants, and muscle relaxants or have hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system.
2. Pregnant women are excluded from participation. Women of child-bearing potential will be offered a pregnancy screening test and excluded with a positive test.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DPI-386 Nasal Gel

DPI-386 Nasal Gel, 0.4 mg

experimental: Placebo Comparator

Placebo Nasal Gel

experimental: DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg

8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL

experimental: Placebo Comparator and Sensory Augmentation Placebo Nasal Gel

8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL

Interventions

DPI-386 Nasal Gel

Subjects will self-administer DPI-386 Nasal Gel.

Placebo Nasal Gel

Subjects will self-administer Placebo Nasal Gel.

DPI-386 Nasal Gel

Subjects will self-administer DPI-386 Nasal Gel. Vibrotactile feedback of tilt direction and magnitude will be provided on a sensory augmentation belt worn by the subject.

Placebo Nasal Gel

Subjects will self-administer Placebo Nasal Gel.

Vibrotactile feedback of tilt direction and magnitude will be provided on a sensory augmentation belt worn by the subject.

Primary outcome measure

  • Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale [ Time Frame: 45 minutes ]

Central Contacts and Locations

Central contacts

Locations

NASA Johnson Space Center Neuroscience Laboratory

Recruiting

Houston, Texas, United States, 77058

More Information

Sponsor

Repurposed Therapeutics, Inc.

Last update posted

May 17, 2024

Last verified

May, 2024

Keywords

  • wave motion
  • eye-hand coordination
  • artificial horizon

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 2024-05-17.