Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

• ClinicalTrials.gov Identifier: NCT02155309
• Recruitment Status: Terminated
• First Posted: June 4, 2014
• Results First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Sponsor: Repurposed Therapeutics, Inc.
• Information provided by (Responsible Party): Repurposed Therapeutics, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Motion Sickness	Drug: Scopolamine; Drug: Placebo	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness
• Study Start Date: June 2014
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Efficacy: Number of Head Movements During Rotation [ Time Frame: 40 min ]
   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).

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Ohio

Naval Medical Research Unit

Dayton, Ohio, United States, 45433

Sponsors and Collaborators

Repurposed Therapeutics, Inc.

Investigators

• Principal Investigator: Willliam J Becker, Phd; Naval Medical Research Unit - Dayton

More Information

Publications:

Klöcker 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.

• Responsible Party: Repurposed Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02155309
• Other Study ID Numbers: NAMRUD.2013.0004
• First Posted: June 4, 2014
• Results First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Repurposed Therapeutics, Inc.:

scopolamine; motion; sickness

Additional relevant MeSH terms:

Motion Sickness; 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