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The Prevention and Treatment of Nausea Associated With Motion Sickness

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ClinicalTrials.gov Identifier: NCT03986905
Recruitment Status : Active, not recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Repurposed Therapeutics, Inc.

Brief Summary:
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-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 nausea associated with motion sickness. The study will be conducted aboard an ocean going vessel to obtain data in a real world environment. 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 100 subjects per arm, for a total of 300 subjects (n=300). Multiple voyages with the same vessel will be used until the required enrollment is completed. 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, and placebo nasal gel + TDS patch.

Condition or disease Intervention/treatment Phase
Motion Sickness Drug: Scopolamine Nasal Gel Other: Placebo Phase 3

Detailed Description:
The investigational product will be administered using a delivery device comprised of: (a) a vial prefilled with DPI-386 Nasal Gel or placebo nasal gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. The DPI 386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". The placebo nasal gel product is the same but does not contain scopolamine HBr. Each vial of DPI 386 Nasal Gel or placebo nasal gel is a multi-dose product, sufficient for three days of dosing (two doses per day). Each pumping action is designed to deliver a single 0.12 g dose. Each vial/delivery device must be primed by the subject prior to first dose delivery for that vial. Each time a new bottle is used, it needs to be initially primed with 5 actuations. The 6th actuation is the first dose and subsequent actuations are doses 2-6 of that bottle. No re-priming is needed at all. Subjects will be trained in priming by research staff, and all priming will be performed under supervision by the research staff. All subjects will self-administer the nasal gel twice daily over the three day treatment period, with no more than two doses every 24 hours, unless a third dose is deemed necessary by the PI or qualified designee, and the two daily doses separated by a minimum of six hours ± 15 minutes

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: A double-dummy design will be used to mask the treatment assignment. A double-dummy design will be used to mask the treatment assignment. 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.
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: Scopolamine Nasal Gel
DPI-386 Nasal Gel + placebo patch
Drug: Scopolamine Nasal Gel
All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
Other Name: Scopolamine Patch

Other: Placebo
placebo nasal gel + placebo patch
Other Name: Placebo Patch and Placebo Nasal Gel

Placebo Comparator: Placebo
placebo nasal gel + placebo patch
Other: Placebo
placebo nasal gel + placebo patch
Other Name: Placebo Patch and Placebo Nasal Gel

Active Comparator: TDS Patch
placebo nasal gel + TDS patch
Drug: Scopolamine Nasal Gel
All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
Other Name: Scopolamine Patch

Other: Placebo
placebo nasal gel + placebo patch
Other Name: Placebo Patch and Placebo Nasal Gel




Primary Outcome Measures :
  1. The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage [ Time Frame: During three consecutive days ]
    The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
  • 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 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.

Exclusion Criteria:

  • 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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986905


Locations
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United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
Sponsors and Collaborators
Repurposed Therapeutics, Inc.
Investigators
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Study Director: Dave Helton Repurposed Therapeutics

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Responsible Party: Repurposed Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03986905     History of Changes
Other Study ID Numbers: DPI-386-MS-21
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In publication and CSR.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Motion Sickness
Signs and Symptoms
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics