Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness

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.

Study Overview

• Status: Terminated
• Conditions: Motion Sickness
• Intervention / Treatment: Drug: Placebo; Drug: Scopolamine

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45433
      • Naval Medical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scopolamine; 0.2 mg intranasal scopolamine, single dose	Drug: Scopolamine
Placebo Comparator: Placebo; placebo intranasal (0.1 mg per nostril), single dose	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	40 min

Collaborators and Investigators

• Sponsor: Repurposed Therapeutics, Inc.
• Investigators: Principal Investigator: Willliam J Becker, Phd, Naval Medical Research Unit - Dayton

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: sickness; scopolamine; motion
• Additional Relevant MeSH Terms: Motion Sickness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: NAMRUD.2013.0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No