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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04184115
Other study ID # DPI-386-MS-22
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 9, 2019
Est. completion date June 11, 2019

Study information

Verified date December 2019
Source Repurposed Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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.


Description:

This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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 three arms: DPI-386 nasal gel, placebo nasal gel, and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion sickness. The study will include 34 subjects per arm, for a total of 102 subjects (n=102). A double dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel randomized to one of the following three arms: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.

Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment immediately followed by Treatment Days 2 and 3 at a clinical site or one of its two satellite locations.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DPI-386 Nasal Gel
1.5 mg reservoir of scopolamine to be delivered over a 72-hour period
Placebos
Placebo Nasal Gel and placebo patch

Locations

Country Name City State
United States Collaborative Neuroscience Network, LLC Long Beach California

Sponsors (1)

Lead Sponsor Collaborator
Repurposed Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of subjects who developed motion sickness. Number of Subjects who developed motion sickness 8 hours
Primary Adverse Event (AE) Reporting of DPI-386 Number of subjects with indicated AEs receiving DPI-386 7 weeks
Secondary Severity of nausea as measured by the Visual Analog Scale (VAS) VAS - Respondents specify their degree of nausea by indicating a point along a continuous 100 mm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and a higher score means more severe degree of nausea (Spinks & Wasiak, 2011). During the 8 hour voyage on Treatment Day 1.
Secondary Severity of motion sickness as measured by the Motion Sickness Assessment Questionnaire (MSAQ) over the treatment period. MSAQ - The MSAQ was designed to measure motion sickness as a multi-dimensional construct, with the understanding that when an individual states they are experiencing motion sickness, it is unlikely a single symptom, but rather a complex set of symptoms, with varying levels of severity. Sixteen symptoms are listed, with symptoms differentiated along four dimensions: gastrointestinal, central, peripheral, and sopite-related. Each symptom is scored from 1 to 9 in severity and scores then calculated. All 16 items were collected from the general public instead of experts, allowing for a more accurate wording of the symptomology experienced by persons outside of physiological sciences. The MSAQ has been repeatedly validated and is strongly correlated with both the Pensacola Diagnostic index (r = 0.81, p < 0.001) and the Nausea Profile (r = 0.92, p < 0.001). During the 8 hour voyage on Treatment Day 1.
Secondary 3. Cognition as measured by the Automated Neuropsychological Assessment Metrics (ANAM). This battery consists of the ANAM CORE battery plus the Running Memory Continuous Performance Test (CPT). During all three Treatment Days.
Secondary Pharmacokinetic parameters of DPI-386 to be measured will include Maximum Observed Plasma Concentrations (Cmax) Pharmacokinetics will be assessed by the amount of total free scopolamine at each time point blood is collected and plasma samples will be assayed for scopolamine using a fully validated LC/MS method. On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Secondary Pharmacokinetic parameters of DPI-386 to be measured will include Time to Reach Maximum Observed Plasma Concentration (tmax). Pharmacokinetics will be assessed by the amount of total free scopolamine at each time point blood is collected and plasma samples will be assayed for scopolamine using a fully validated LC/MS method. On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
Secondary Pharmacokinetic parameters of DPI-386 to be measured will include Area Under the Curve (AUC). Pharmacokinetics will be assessed by the amount of total free scopolamine at each time point blood is collected and plasma samples will be assayed for scopolamine using a fully validated LC/MS method. On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.
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