Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Motion Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02155309
• Other study ID #: NAMRUD.2013.0004
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 2, 2014
• Last updated: December 15, 2017
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2017
• Source: Repurposed Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Motion Sickness

Intervention

Drug:
• Scopolamine

• Placebo

Locations

Country	Name	City	State
United States	Naval Medical Research Unit	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Repurposed Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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