Clinical trial NCT02155309: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Motion Sickness
Keywords: scopolamine
motion
sickness
Lead sponsor: Repurposed Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy: Number of Head Movements During Rotation
timeFrame: 40 min
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Naval Medical Research Unit
state: Ohio
Study officials:
affiliation: Naval Medical Research Unit - Dayton
name: Willliam J Becker, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.