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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scopolamine | Experimental | 0.2 mg intranasal scopolamine, single dose |
|
| Placebo | Placebo Comparator | placebo intranasal (0.1 mg per nostril), single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scopolamine | Drug |
| ||
| Placebo |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willliam J Becker, Phd | Naval Medical Research Unit - Dayton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Research Unit | Dayton | Ohio | 45433 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11297908 | Background | 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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For the Pharmacokinetics part, 21 subjects were screened, and 13 completed the pharmacokinetics portion. For Efficacy, 42 subjects were screened, and 23 completed, with one removed from efficacy tabulated results due to noncompliance with study protocol. All subjects randomized into treatment order with cross-over design.
This study enrolled subjects who were active-duty military or reserves on active duty status between the ages of 18 and 59 from the Wright-Patterson Air Force Base located in Dayton, Ohio. The last subjects completed in August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | PK: Scopolamine Only, Open-label | Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose. |
| FG001 | Efficacy: Scopolamine, Then Placebo | Subjects received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) for the first of two Efficacy sessions, and then one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for the second Efficacy session. A minimum of one week separated the two sessions. Each session was identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. |
| FG002 | Efficacy: Placebo, Then Scopolamine | Subjects received one dose of 0.2 mg intranasal placebo (0.1 mg per nostril) for the first of two Efficacy sessions, and then one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) for the second Efficacy session. A minimum of one week separated the two sessions. Each session was identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PK: Scopolamine Only, Open-label | Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Number of head tilts | 40 min |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PK: Scopolamine Only, Open-label | Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nonserious AEs | General disorders | Systematic Assessment | Nonserious adverse events were AEs lacking clinical significance and monitored/assessed without regard to the specific Adverse Event Term. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Geyer, MPH | Henry Jackson Military Foundation for Naval Medical Research Unit - Dayton | (937) 938-3922 | daniel.geyer.1.ctr@us.af.mil |
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| ID | Term |
|---|---|
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012601 | Scopolamine |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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|
| Efficacy: All Study Participants (Crossover, Double-Blind) |
Double-blind, placebo-controlled, cross-over design. Study medications (0.2 mg of intranasal scopolamine and 0.2 mg of intranasal placebo) were randomized, blinded, and delivered in identical containers. Each subject participated in two sessions separated by minimum of one week, each session identical except for contents of intranasal spray. Order of treatment and placebo administration randomized. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | One subject was not analyzed due to protocol noncompliance. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Efficacy: Scopolamine and Placebo (Crossover, Double-blind) |
Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions. |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 11 |
| 13 |
| EG001 | Efficacy: Scopolamine (Crossover, Double-blind) | Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions. | 0 | 23 | 0 | 23 | 18 | 23 |
| EG002 | Efficacy: Placebo (Crossover, Double-blind) | Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions. | 0 | 23 | 0 | 23 | 19 | 23 |
|
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |