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Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Primary Purpose

Motion Sickness

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Scopolamine
Placebo
Sponsored by
Repurposed Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness focused on measuring scopolamine, motion, sickness

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females, 18 to 59 years old, inclusive, in good general health as determined by physical examination and without clinically significant laboratory profiles
  • Normal weight for body size, based on Physical Readiness Test Body Composition Assessment (PPRTBCA) table
  • Willing and able to comply with study requirements and restrictions; and read and sign the informed consent.

Exclusion Criteria:

  • Known and/or documented drug allergies, especially to scopolamine
  • Use of an investigational drug within 30 days of starting the study
  • Smoking or use of tobacco products, including "chew" or "snuff", within six months
  • Blood donation or significant blood loss within 30 days of starting the study
  • Significant gastrointestinal disorder, asthma, or seizure disorders
  • History of narrow-angle glaucoma
  • History of urinary retention problems
  • History of alcohol or other drug abuse
  • Pregnancy or suspected pregnancy, or lactation
  • Hematocrit values less than 41% for males and 37% for females
  • Recent nasal, nasal sinus or nasal mucosa surgery
  • Use of prescription, over-the-counter, or herbal medication in past 7 days

Sites / Locations

  • Naval Medical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Scopolamine

Placebo

Arm Description

0.2 mg intranasal scopolamine, single dose

placebo intranasal (0.1 mg per nostril), single dose

Outcomes

Primary Outcome Measures

Efficacy: Number of Head Movements During Rotation
During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).

Secondary Outcome Measures

Full Information

First Posted
June 2, 2014
Last Updated
December 15, 2017
Sponsor
Repurposed Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02155309
Brief Title
Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray
Official Title
Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Business reason
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repurposed Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.
Detailed Description
Part 1: The pharmacokinetic (PK) phase Objective: To determine the bioavailability and amount of scopolamine absorbed after administration of 0.2 mg intranasal scopolamine at regular intervals across 8 hours post- dose. Hypothesis: Detectable levels of Intranasal scopolamine (INSCOP) will be present in subject plasma within 15 minutes post-dose; mean time to Cmax (maximum plasma concentration) will be less than 1.5 hr. Part 2: The Efficacy phase Objective: To determine the effectiveness, cognitive performance effects, and medication side-effect profile of 0.2 mg intranasal scopolamine spray as a motion sickness (MS) countermeasure. Hypothesis: The primary hypothesis is that the INSCOP spray will be more efficacious against MS than placebo, without statistically significant cognitive performance side-effects. Specifically, participants will tolerate significantly more provocative head tilts in the INSCOP condition than in the placebo condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
Keywords
scopolamine, motion, sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scopolamine
Arm Type
Experimental
Arm Description
0.2 mg intranasal scopolamine, single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo intranasal (0.1 mg per nostril), single dose
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Efficacy: Number of Head Movements During Rotation
Description
During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).
Time Frame
40 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females, 18 to 59 years old, inclusive, in good general health as determined by physical examination and without clinically significant laboratory profiles Normal weight for body size, based on Physical Readiness Test Body Composition Assessment (PPRTBCA) table Willing and able to comply with study requirements and restrictions; and read and sign the informed consent. Exclusion Criteria: Known and/or documented drug allergies, especially to scopolamine Use of an investigational drug within 30 days of starting the study Smoking or use of tobacco products, including "chew" or "snuff", within six months Blood donation or significant blood loss within 30 days of starting the study Significant gastrointestinal disorder, asthma, or seizure disorders History of narrow-angle glaucoma History of urinary retention problems History of alcohol or other drug abuse Pregnancy or suspected pregnancy, or lactation Hematocrit values less than 41% for males and 37% for females Recent nasal, nasal sinus or nasal mucosa surgery Use of prescription, over-the-counter, or herbal medication in past 7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willliam J Becker, Phd
Organizational Affiliation
Naval Medical Research Unit - Dayton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Research Unit
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11297908
Citation
Klocker N, Hanschke W, Toussaint S, Verse T. Scopolamine nasal spray in motion sickness: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo. Eur J Pharm Sci. 2001 May;13(2):227-32. doi: 10.1016/s0928-0987(01)00107-5.
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Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

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