Trial Outcomes & Findings for Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray (NCT NCT02155309)
NCT ID: NCT02155309
Last Updated: 2018-01-17
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
63 participants
Primary outcome timeframe
40 min
Results posted on
2018-01-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
13
|
|
Overall Study
COMPLETED
|
13
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
One subject was not analyzed due to protocol noncompliance.
Baseline characteristics by cohort
| Measure |
PK: Scopolamine Only, Open-label
n=13 Participants
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.
|
Efficacy: All Study Participants (Crossover, Double-Blind)
n=23 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
23 Participants
n=23 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
30.31 Years
STANDARD_DEVIATION 12.59 • n=13 Participants
|
30.96 Years
STANDARD_DEVIATION 10.86 • n=23 Participants
|
30.72 Years
STANDARD_DEVIATION 11.16 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants • One subject was not analyzed due to protocol noncompliance.
|
5 Participants
n=22 Participants • One subject was not analyzed due to protocol noncompliance.
|
8 Participants
n=35 Participants • One subject was not analyzed due to protocol noncompliance.
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants • One subject was not analyzed due to protocol noncompliance.
|
17 Participants
n=22 Participants • One subject was not analyzed due to protocol noncompliance.
|
27 Participants
n=35 Participants • One subject was not analyzed due to protocol noncompliance.
|
|
Region of Enrollment
United States
|
13 Participants
n=13 Participants
|
23 Participants
n=23 Participants
|
36 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 40 minDuring 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).
Outcome measures
| Measure |
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.
|
Efficacy: Scopolamine and Placebo (Crossover, Double-blind)
n=22 Participants
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.
|
|---|---|---|
|
Efficacy: Number of Head Movements During Rotation
Head Tilts: Scopolamine Condition
|
—
|
222.5 Number of head tilts
Standard Deviation 105
|
|
Efficacy: Number of Head Movements During Rotation
Head Tilts: Placebo Condition
|
—
|
191.7 Number of head tilts
Standard Deviation 95.1
|
Adverse Events
PK: Scopolamine Only, Open-label
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Efficacy: Scopolamine (Crossover, Double-blind)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Efficacy: Placebo (Crossover, Double-blind)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PK: Scopolamine Only, Open-label
n=13 participants at risk
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.
|
Efficacy: Scopolamine (Crossover, Double-blind)
n=23 participants at risk
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.
|
Efficacy: Placebo (Crossover, Double-blind)
n=23 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Nonserious AEs
|
84.6%
11/13 • Number of events 42
|
78.3%
18/23 • Number of events 82
|
82.6%
19/23 • Number of events 65
|
Additional Information
Daniel Geyer, MPH
Henry Jackson Military Foundation for Naval Medical Research Unit - Dayton
Phone: (937) 938-3922
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place