Trial Outcomes & Findings for Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica (NCT NCT03179345)
NCT ID: NCT03179345
Last Updated: 2020-06-01
Results Overview
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Baseline and Hour 3 on Day 3
Results posted on
2020-06-01
Participant Flow
A total of 32 healthy subjects enrolled in this crossover study. Each subject was randomly assigned to 1 out of 4 treatment sequences. Abbreviations: Gral = Gralise®; Neur = Neurontin®; Lyr = Lyrica®; Plbo = Placebo.
Participant milestones
| Measure |
Gral First, Then Neur, Lyr, and Plbo
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Neur First, Then Plbo, Gral, and Lyr
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Lyr First, Then Gral, Plbo, and Neur
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Plbo First, Then Lyr, Neur, and Gral
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
Received Gralise®
|
8
|
7
|
7
|
6
|
|
Overall Study
Received Neurontin®
|
8
|
8
|
7
|
8
|
|
Overall Study
Received Lyrica®
|
8
|
7
|
8
|
8
|
|
Overall Study
Received Placebo
|
8
|
7
|
7
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
Baseline characteristics by cohort
| Measure |
Gral First, Then Neur, Lyr, and Plbo
n=8 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Neur First, Then Plbo, Gral, and Lyr
n=8 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Lyr First, Then Gral, Plbo, and Neur
n=8 Participants
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Plbo First, Then Lyr, Neur, and Gral
n=8 Participants
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
All treatments were administered following a meal.
Each treatment period was separated by a 7-day washout interval.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 5.29 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 4.06 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 6.23 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Hour 3 on Day 3Population: The above is the only Primary Outcome Measure (comparing the SDLP between Gralise® and Neurontin®).
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin®
|
0.255 feet
Standard Error 0.0781
|
0.395 feet
Standard Error 0.0763
|
0.135 feet
Standard Error 0.0770
|
—
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Population: The above is a Secondary Outcome Measure (comparing the SDLP between Gralise® and Lyrica®).
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=30 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica®
|
0.255 feet
Standard Error 0.0781
|
0.356 feet
Standard Error 0.0770
|
0.135 feet
Standard Error 0.0770
|
—
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET)
|
0.00 msec
Standard Error 0.013
|
0.00 msec
Standard Error 0.012
|
-0.01 msec
Standard Error 0.012
|
-0.00 msec
Standard Error 0.012
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Cogstate - The Groton Maze Learning test is a measure Executive Function. Total number of errors made while attempting to learn the same hidden pathway across the consecutive learning trials performed at a single assessment. Lower score means better performance. Higher change from baseline means better performance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT).
|
-0.40 Number of errors on test
Standard Error 2.484
|
-0.01 Number of errors on test
Standard Error 2.385
|
-0.64 Number of errors on test
Standard Error 2.419
|
3.32 Number of errors on test
Standard Error 2.420
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Cogstate - Identification Task (IDN) assesses Attention. Score is speed of performance (mean of the log10 transformed reaction times for correct responses). Lower score (quicker speed) is better performance. Higher change from baseline means better performance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN).
|
-0.00 Score on Scale
Standard Error 0.000
|
0.00 Score on Scale
Standard Error 0.000
|
-0.00 Score on Scale
Standard Error 0.000
|
0.01 Score on Scale
Standard Error 0.000
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Cogstate - International Shopping List (ISL) test is a measure of verbal learning and uses a well-validated list-learning paradigm. Total number of correct responses remembering the word list on three consecutive trials at a single assessment. Higher score is better performance. Higher change from baseline means better performance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL)
|
0.36 Score on Scale
Standard Error 0.684
|
0.82 Score on Scale
Standard Error 0.648
|
0.03 Score on Scale
Standard Error 0.660
|
-0.01 Score on Scale
Standard Error 0.660
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Cogstate - The One Card Learning Test (OCLT) is a measure of visual learning and uses a well-validated pattern separation paradigm with playing card stimuli. Higher Score is better performance. Higher change from baseline means better performance.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT).
|
0.02 Score on Scale
Standard Error 0.021
|
0.06 Score on Scale
Standard Error 0.020
|
0.00 Score on Scale
Standard Error 0.020
|
0.03 Score on Scale
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS).
|
.774 units on a scale
Standard Error .2985
|
.264 units on a scale
Standard Error .2876
|
.868 units on a scale
Standard Error .2913
|
.264 units on a scale
Standard Error .2914
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Population: Full Analysis Set
Portland Neurotoxicity Scale (PNS) comprises 15 questions measured on a 10-point scale. \[1=No problem, 2, 3, 4, 5=Often a problem, 6, 7, 8, 9, 10=Severe problem\] in 16 categories. Each question was analyzed and is presented in the same way as the primary endpoints.
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=31 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=31 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=31 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Vision (blurring, double vision)
|
0.036 scores on a scale
Standard Error 0.1274
|
0.322 scores on a scale
Standard Error 0.1235
|
0.249 scores on a scale
Standard Error 0.1249
|
0.115 scores on a scale
Standard Error 0.1249
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Energy Level (get up and go)
|
0.099 scores on a scale
Standard Error 0.1811
|
0.256 scores on a scale
Standard Error 0.1743
|
0.315 scores on a scale
Standard Error 0.1766
|
0.331 scores on a scale
Standard Error 0.1766
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Memory (ability to remember people, places, or thi
|
0.077 scores on a scale
Standard Error 0.1498
|
0.123 scores on a scale
Standard Error 0.1441
|
0.125 scores on a scale
Standard Error 0.1460
|
-0.041 scores on a scale
Standard Error 0.1460
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Walking (balance)
|
0.206 scores on a scale
Standard Error 0.1245
|
0.327 scores on a scale
Standard Error 0.1187
|
0.405 scores on a scale
Standard Error 0.1206
|
0.107 scores on a scale
Standard Error 0.1206
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Interest (in activities)
|
0.046 scores on a scale
Standard Error 0.1174
|
0.030 scores on a scale
Standard Error 0.1130
|
0.096 scores on a scale
Standard Error 0.1145
|
0.070 scores on a scale
Standard Error 0.1145
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Coordination
|
0.180 scores on a scale
Standard Error 0.1338
|
0.392 scores on a scale
Standard Error 0.1289
|
0.350 scores on a scale
Standard Error 0.1306
|
0.218 scores on a scale
Standard Error 0.1306
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Tremor (shakiness)
|
-0.103 scores on a scale
Standard Error 0.0571
|
0.037 scores on a scale
Standard Error 0.0555
|
-0.031 scores on a scale
Standard Error 0.0556
|
0.068 scores on a scale
Standard Error 0.0556
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Concentration (ability to concentrate on a task)
|
0.080 scores on a scale
Standard Error 0.1205
|
0.164 scores on a scale
Standard Error 0.1148
|
0.137 scores on a scale
Standard Error 0.1166
|
0.182 scores on a scale
Standard Error 0.1166
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Speech (slurring words)
|
0.035 scores on a scale
Standard Error 0.0516
|
0.133 scores on a scale
Standard Error 0.0493
|
0.065 scores on a scale
Standard Error 0.0501
|
0.103 scores on a scale
Standard Error 0.0501
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Forgetfulness
|
0.118 scores on a scale
Standard Error 0.1128
|
0.227 scores on a scale
Standard Error 0.1083
|
0.175 scores on a scale
Standard Error 0.1098
|
0.079 scores on a scale
Standard Error 0.1099
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Sleepiness (fatigue, sedation, tiredness)
|
0.693 scores on a scale
Standard Error 0.2928
|
0.635 scores on a scale
Standard Error 0.2802
|
1.176 scores on a scale
Standard Error 0.2843
|
0.541 scores on a scale
Standard Error 0.2844
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Moodiness
|
0.181 scores on a scale
Standard Error 0.1174
|
0.163 scores on a scale
Standard Error 0.1144
|
0.098 scores on a scale
Standard Error 0.1155
|
0.100 scores on a scale
Standard Error 0.1155
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Alertness
|
0.297 scores on a scale
Standard Error 0.1854
|
0.451 scores on a scale
Standard Error 0.1786
|
0.607 scores on a scale
Standard Error 0.1809
|
0.353 scores on a scale
Standard Error 0.1809
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Attention Span
|
0.020 scores on a scale
Standard Error 0.1115
|
0.133 scores on a scale
Standard Error 0.1070
|
0.146 scores on a scale
Standard Error 0.1085
|
0.015 scores on a scale
Standard Error 0.1085
|
|
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
Motivation
|
0.185 scores on a scale
Standard Error 0.1338
|
0.232 scores on a scale
Standard Error 0.1294
|
0.368 scores on a scale
Standard Error 0.1309
|
0.271 scores on a scale
Standard Error 0.1309
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Population: Full Analysis Set
Miles per Hour (mph)
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
|
0.831 mph
Standard Error 0.4844
|
0.947 mph
Standard Error 0.4648
|
0.851 mph
Standard Error 0.4715
|
—
|
SECONDARY outcome
Timeframe: Baseline and Hour 3 on Day 3Population: Full Analysis Set
Miles per Hour (mph)
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=30 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
|
0.831 mph
Standard Error 0.4844
|
1.319 mph
Standard Error 0.4713
|
0.851 mph
Standard Error 0.4715
|
—
|
SECONDARY outcome
Timeframe: Screening to 1 week after Period 4 discharge* Number of subjects with Treatment-Emergent Adverse Events (TEAE) * Number of subjects with Serious Adverse Event (SAE) * Number of subjects discontinued due to Adverse Event (AE)
Outcome measures
| Measure |
Gralise® (Gabapentin)
n=28 Participants
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 Participants
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo
n=31 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 Participants
Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Placebo
|
|---|---|---|---|---|
|
To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.
Subjects Discontinued due to AE
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.
Subjects with TEAE
|
6 participants
|
13 participants
|
16 participants
|
5 participants
|
|
To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.
Subjects with SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Gralise® (Gabapentin)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Neurontin® (Gabapentin)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Lyrica® (Pregabalin)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo (Sugar Pill)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gralise® (Gabapentin)
n=28 participants at risk
Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
|
Neurontin® (Gabapentin)
n=31 participants at risk
Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
|
Lyrica® (Pregabalin)
n=31 participants at risk
Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
|
Placebo (Sugar Pill)
n=30 participants at risk
Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® \& 1 placebo capsule matching the over-encapsulation of doses of Neurontin® \& Lyrica®.
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
10.7%
3/28 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
22.6%
7/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
12.9%
4/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
3.3%
1/30 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
12.9%
4/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
19.4%
6/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
0.00%
0/30 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
0.00%
0/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
16.1%
5/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
3.3%
1/30 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
3.6%
1/28 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
6.5%
2/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
9.7%
3/31 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
0.00%
0/30 • 7 weeks
Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
- Publication restrictions are in place
Restriction type: OTHER