Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance

NCT05886660 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NASA 0354 (Aim 1)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

wave motion; eye-hand coordination; artificial horizon

Outcome Measures

Primary Outcomes (1)

• Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale

  The PDI scale ranges from 0 to 16 with higher numbers reflecting greater symptom severity (in this study a PDI score of 8 will be used as a motion sickness (MS) endpoint). During each session, the primary motion sickness symptoms will be recorded every minute during the capsule wave motion stimulation through the MS endpoint (PDI score ≥ 8 points) up to 45 min total.

  45 minutes

Secondary Outcomes (4)

• Motion sickness symptom severity using a Subjective Discomfort Rating (SDR)

  45 minutes

• Time to MS endpoint (based on PDI score of 8 points)

  45 minutes

• Performance measures: response time

  45 minutes

• Performance measures: error

  45 minutes

Study Arms (4)

DPI-386 Nasal Gel

EXPERIMENTAL

DPI-386 Nasal Gel, 0.4 mg

Drug: DPI-386 Nasal Gel

Placebo Comparator

EXPERIMENTAL

Placebo Nasal Gel

Drug: Placebo Nasal Gel

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

EXPERIMENTAL

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

Drug: DPI-386 Nasal Gel

Placebo Comparator and Sensory Augmentation Placebo Nasal Gel

EXPERIMENTAL

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

Drug: Placebo Nasal Gel

Interventions

DPI-386 Nasal Gel DRUG

Subjects will self-administer DPI-386 Nasal Gel.

Also known as: scopolamine

DPI-386 Nasal Gel

Placebo Nasal Gel DRUG

Subjects will self-administer Placebo Nasal Gel.

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

• 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."
• No participants should have neurologic, vestibular or autonomic disorders, or medical conditions that could be worsened by scopolamine (narrow-angle glaucoma or urinary retention
• 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.

You may not qualify if:

• 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.
• Pregnant women are excluded from participation. Women of child-bearing potential will be offered a pregnancy screening test and excluded with a positive test.

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

NASA Johnson Space Center Neuroscience Laboratory

Houston, Texas, 77058, United States

RECRUITING

MeSH Terms

Conditions

Space Motion Sickness; 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

• Scott J Wood, PhD

  National Aeronautics and Space Administration (NASA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barry Feinberg, MD

CONTACT

314-697-1330; bfeinberg@defenderpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A randomized double-blind (subjects and test operators) cross-over design.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 2, 2023
• Study Start: January 21, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)