Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness

NCT04184115 | Completed Phase 3 FDA Drug

• 1 other identifier: DPI-386-MS-22
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (2)

• Incidence of subjects who developed motion sickness.

  Number of Subjects who developed motion sickness

  8 hours

• Adverse Event (AE) Reporting of DPI-386

  Number of subjects with indicated AEs receiving DPI-386

  7 weeks

Secondary Outcomes (6)

• Severity of nausea as measured by the Visual Analog Scale (VAS)

  During the 8 hour voyage on Treatment Day 1.

• Severity of motion sickness as measured by the Motion Sickness Assessment Questionnaire (MSAQ) over the treatment period.

  During the 8 hour voyage on Treatment Day 1.

• 3. Cognition as measured by the Automated Neuropsychological Assessment Metrics (ANAM).

  During all three Treatment Days.

• Pharmacokinetic parameters of DPI-386 to be measured will include Maximum Observed Plasma Concentrations (Cmax)

  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.

• Pharmacokinetic parameters of DPI-386 to be measured will include Time to Reach Maximum Observed Plasma Concentration (tmax).

  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.

Study Arms (3)

DPI-386 Nasal Gel + placebo patch

EXPERIMENTAL

DPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr

Drug: DPI-386 Nasal Gel; Drug: Placebos

Placebo nasal gel + Placebo patch

PLACEBO COMPARATOR

Placebo

Drug: Placebos

placebo nasal gel + TDS patch

ACTIVE COMPARATOR

Transderm Scop® is a commercial transdermal scopolamine (TDS) patch worn behind the ear containing a 1.5 mg reservoir of scopolamine to be delivered over a 72-hour period.

Drug: DPI-386 Nasal Gel; Drug: Placebos

Interventions

DPI-386 Nasal Gel DRUG

1.5 mg reservoir of scopolamine to be delivered over a 72-hour period

Also known as: Transderm Scop®

DPI-386 Nasal Gel + placebo patch; placebo nasal gel + TDS patch

Placebos DRUG

Placebo Nasal Gel and placebo patch

DPI-386 Nasal Gel + placebo patch; Placebo nasal gel + Placebo patch; placebo nasal gel + TDS patch

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 18 to 59 (inclusive).
• At least two responses on the MSSQ must be "Sometimes" or "Frequently".
• 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.
• For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. The test must be negative within seven days of the Treatment Day 1.
• 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.

You may not qualify if:

• Pregnancy, lactation, or positive urine pregnancy test within seven days of Treatment Day 1.
• 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.
• Having donated blood or plasma or suffered significant blood loss within the past 30 days.
• Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or qualified designee:
• Significant gastrointestinal disorder, asthma, or seizure disorders.
• History of cardiovascular disease.

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead

Study Sites (1)

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

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

• David R Helton

  Repurposed Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: study is double-blinded placebo controlled for all treatment arms. All DPI-386 Nasal Gel and placebo nasal gel vials are opaque and indistinguishable. The DPI-386 Nasal Gel and placebo nasal gels are identical in color and viscosity, and without identifiable smell. Each placebo patch is similar in color and size as the TDS patch but does not deliver any medication or contain any excipients. A designated independent (unblinded) applicator will administer all patch application and removal, including an opaque waterproof bandage cover over the patch, to further prevent unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: December 3, 2019
• Study Start: June 9, 2019
• Primary Completion: June 11, 2019
• Study Completion: June 11, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)