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Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects

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ClinicalTrials.gov Identifier: NCT03988530
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Repurposed Therapeutics, Inc.

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI 386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness in Senior Subjects With Open-Label Follow-Up

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

Detailed Description:

This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study with open-label follow-up 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 two arms: DPI-386 nasal gel and placebo nasal gel for Treatment Day 1. Treatment Day 1 will include 50 subjects per arm, for a total of 100 subjects (n=100). All 100 subjects from Treatment Day 1 will receive open-label DPI-386 Nasal Gel for Treatment Days 2-4 (50 of these were originally randomized to receive placebo prior to receipt of the investigational product.).

Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment and within 30 days of Treatment Day 1, Treatment Days 2-4 will take place at the clinical site.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This study is double-blinded placebo controlled for all treatment arms on Treatment Day 1. 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. Treatment Days 2-4 are open-label.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects With Open-Label Follow-Up
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Active Comparator: DPI-386 Nasal Gel
DPI-386 Nasal Gel (0.2 mg / 0.12 g)
Drug: Scopolamine
Subjects will self-administer DPI-386 Nasal Gel (0.2 mg / 0.12 g) or placebo nasal gel (0.12 g) on Treatment Day 1, and on Treatment Days 2 -4 all subjects will self administer DPI-386 Nasal Gel (0.2 mg / 0.12 g).
Other Name: DPI-386 Nasal Gel

Placebo Comparator: Placebo Nasal Gel
placebo nasal gel (0.12 g)
Other: Placebo Nasal Gel
Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.




Primary Outcome Measures :
  1. The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication). [ Time Frame: During voyage on Treatment Day 1. ]
    The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication) during an 8 hour voyage on Treatment Day 1.

  2. Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events. [ Time Frame: During all four Treatment Days ]
    Safety endpoint is the incidence of adverse events.


Secondary Outcome Measures :
  1. Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period. [ Time Frame: During Treatment Day 1 voyage. ]
    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).

  2. Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT). [ Time Frame: During Treatment Day 1 voyage ]
    The PVT is a neurocognitive assessment that measures alertness and tests sustained attention and reaction time. It was originally developed for sleep studies, and involves simple reaction time testing by requiring the participant to push a button as soon as the stimulus (a light) appears. After a response, the reaction time (in ms) is displayed. The inter-stimulus interval varies from two to 10 seconds, so it is not predictable, and the entire task takes 10 minutes (Dorrian, Rogers, & Dinges, 2005). There are also shorter versions which have been validated as reasonable substitutes for the 10 minute version, such as the five minute (Lamond, Dawson, & Roach, 2005)) and three minute versions (Grant, et al., (2017).

  3. Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel. [ Time Frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4. ]
    PK parameters to be measured by Maximum Observed Plasma Concentration (Cmax)

  4. Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel. [ Time Frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4. ]
    PK parameters to be measured by Time to Reach Maximum Observed Plasma Concentration (Tmax).

  5. Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel. [ Time Frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4. ]
    PK parameters to be measured by Area Under the Curve (AUC)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of a signed and dated Informed Consent Form (ICF).
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female, aged 55 and over.
  4. In good general health as evidenced by medical history with no recent history or current diagnosis of uncontrolled clinical problems as as-sessed by the Principal Investigator (PI) or qualified designee.
  5. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
  6. Agreement to adhere to the following lifestyle compliance considera-tions:

    • Refrain from consumption of grapefruit and any substance contain-ing 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 medi-cation and during the three Treatment Days.

Exclusion Criteria:

  1. Known allergic reactions to scopolamine or other anticholinergics.
  2. 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)
  3. Hospitalization or significant surgery requiring hospital admittance within the past six months.
  4. Treatment with another investigational drug or other intervention with-in the past 30 days.
  5. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
  6. 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.
    • History of vestibular disorders.
    • History of narrow-angle glaucoma.
    • History of urinary retention problems.
    • History of alcohol or drug abuse.
    • 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): NCT03988530


Contacts
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Contact: Laurie Mellott 949-428-6617 laurie.mellot@clindatrix.com

Locations
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United States, California
Collaborative Neuroscience Network, LLC Recruiting
Long Beach, California, United States, 90806
Contact: Jay Saifuki    562-304-1740      
Sponsors and Collaborators
Repurposed Therapeutics, Inc.
Investigators
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Study Director: Daved R Helton Repurposed Therapeutics

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Responsible Party: Repurposed Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03988530     History of Changes
Other Study ID Numbers: DPI-386-MS-24
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Repurposed Therapeutics, Inc.:
Anticholinergic
Scopolamine

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