Healthy
Conditions
Keywords
Volunteer, Pharmacodynamics, Pharmacokinetics
Brief summary
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.
Interventions
DRUGGabapentin
DRUGPregabalin
OTHERPlacebo
Sponsors
Depomed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 40 and 80 years of age, inclusive. * Body weight \> 50 kg and BMI between 18 and 32 kg/m2, inclusive. * Able to give informed consent. * Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee. * Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee. * Karolinska Sleep Scale (KSS) score of \<=5. * Other criteria apply.
Exclusion criteria
* Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals. * Pregnant or lactating or considered at risk of pregnancy. * Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation. * Impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥2 times the upper limit of normal \[ULN\] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure. * Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2. * History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia. * Other criteria apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® | Baseline and Hour 3 on Day 3 | SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) | Baseline and Hour 3 on Day 3 | Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance. |
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). | Baseline and Hour 3 on Day 3 | Cogstate - 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. |
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN). | Baseline and Hour 3 on Day 3 | Cogstate - 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. |
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) | Baseline and Hour 3 on Day 3 | Cogstate - 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. |
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). | Baseline and Hour 3 on Day 3 | Cogstate - 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. |
| Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® | Baseline and Hour 3 on Day 3 | SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance. |
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Baseline and Hour 3 on Day 3 | 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. |
| Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | Baseline and Hour 3 on Day 3 | Miles per Hour (mph) |
| Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | Baseline and Hour 3 on Day 3 | Miles per Hour (mph) |
| To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | 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) |
| Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). | Baseline and Hour 3 on Day 3 | Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Gral First, Then Neur, Lyr, and Plbo | Neur First, Then Plbo, Gral, and Lyr | Lyr First, Then Gral, Plbo, and Neur | Plbo First, Then Lyr, Neur, and Gral | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 5.32 | 47.6 years STANDARD_DEVIATION 5.29 | 51.0 years STANDARD_DEVIATION 9.35 | 46.8 years STANDARD_DEVIATION 4.06 | 48.6 years STANDARD_DEVIATION 6.23 |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 5 Participants | 7 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 28 | 11 / 31 | 14 / 31 | 2 / 30 |
| serious Total, serious adverse events | 0 / 28 | 0 / 31 | 0 / 31 | 0 / 30 |
Outcome results
Primary
Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator 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.
Time frame: Baseline and Hour 3 on Day 3
Population: The above is the only Primary Outcome Measure (comparing the SDLP between Gralise® and Neurontin®).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® | 0.395 feet | Standard Error 0.0763 |
| Placebo | Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® | 0.135 feet | Standard Error 0.077 |
p-value: 0.027595% CI: [-0.266, -0.016]ANOVA
p-value: 0.061195% CI: [-0.006, 0.245]ANOVA
Secondary
Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
Miles per Hour (mph)
Time frame: Baseline and Hour 3 on Day 3
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | 0.831 mph | Standard Error 0.4844 |
| Neurontin® (Gabapentin) | Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | 1.319 mph | Standard Error 0.4713 |
| Placebo | Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | 0.851 mph | Standard Error 0.4715 |
p-value: 0.366695% CI: [-1.556, 0.581]ANOVA
p-value: 0.970595% CI: [-1.089, 1.049]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET)
Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance.
Time frame: Baseline and Hour 3 on Day 3
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) | 0.00 msec | Standard Error 0.012 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) | -0.01 msec | Standard Error 0.012 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) | -0.00 msec | Standard Error 0.012 |
p-value: 0.994695% CI: [-0.02, 0.02]ANOVA
p-value: 0.167395% CI: [-0.01, 0.04]ANCOVA
p-value: 0.620895% CI: [-0.02, 0.03]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT).
Cogstate - 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.
Time frame: Baseline and Hour 3 on Day 3
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). | -0.01 Number of errors on test | Standard Error 2.385 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). | -0.64 Number of errors on test | Standard Error 2.419 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). | 3.32 Number of errors on test | Standard Error 2.42 |
p-value: 0.879995% CI: [-5.59, 4.8]ANOVA
p-value: 0.927795% CI: [-4.97, 5.45]ANOVA
p-value: 0.158795% CI: [-8.94, 1.49]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN).
Cogstate - 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.
Time frame: Baseline and Hour 3 on Day 3
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | 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 |
| 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 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN). | 0.01 Score on Scale | Standard Error 0 |
p-value: 0.711195% CI: [-0.03, 0.02]ANOVA
p-value: 0.904895% CI: [-0.02, 0.02]ANOVA
p-value: 0.326295% CI: [-0.03, 0.01]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL)
Cogstate - 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.
Time frame: Baseline and Hour 3 on Day 3
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) | 0.82 Score on Scale | Standard Error 0.648 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) | 0.03 Score on Scale | Standard Error 0.66 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) | -0.01 Score on Scale | Standard Error 0.66 |
p-value: 0.59595% CI: [-2.18, 1.26]ANOVA
p-value: 0.705795% CI: [-1.4, 2.06]ANOVA
p-value: 0.674195% CI: [-1.36, 2.1]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT).
Cogstate - 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.
Time frame: Baseline and Hour 3 on Day 3
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). | 0.06 Score on Scale | Standard Error 0.02 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). | 0.00 Score on Scale | Standard Error 0.02 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). | 0.03 Score on Scale | Standard Error 0.02 |
p-value: 0.00795% CI: [-0.08, -0.01]ANOVA
p-value: 0.518395% CI: [-0.02, 0.05]ANOVA
p-value: 0.508495% CI: [-0.05, 0.02]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS).
Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep
Time frame: Baseline and Hour 3 on Day 3
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). | .774 units on a scale | Standard Error 0.2985 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). | .264 units on a scale | Standard Error 0.2876 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). | .868 units on a scale | Standard Error 0.2913 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). | .264 units on a scale | Standard Error 0.2914 |
p-value: 0.102695% CI: [-0.104, 1.124]ANOVA
p-value: 0.763495% CI: [-0.711, 0.523]ANOVA
p-value: 0.104195% CI: [-0.107, 1.127]ANOVA
Secondary
Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
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.
Time frame: Baseline and Hour 3 on Day 3
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Vision (blurring, double vision) | 0.322 scores on a scale | Standard Error 0.1235 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Concentration (ability to concentrate on a task) | 0.164 scores on a scale | Standard Error 0.1148 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Motivation | 0.232 scores on a scale | Standard Error 0.1294 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Forgetfulness | 0.227 scores on a scale | Standard Error 0.1083 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Speech (slurring words) | 0.133 scores on a scale | Standard Error 0.0493 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Sleepiness (fatigue, sedation, tiredness) | 0.635 scores on a scale | Standard Error 0.2802 |
| Neurontin® (Gabapentin) | 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 | 0.123 scores on a scale | Standard Error 0.1441 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Walking (balance) | 0.327 scores on a scale | Standard Error 0.1187 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Alertness | 0.451 scores on a scale | Standard Error 0.1786 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Moodiness | 0.163 scores on a scale | Standard Error 0.1144 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Interest (in activities) | 0.030 scores on a scale | Standard Error 0.113 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Attention Span | 0.133 scores on a scale | Standard Error 0.107 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Coordination | 0.392 scores on a scale | Standard Error 0.1289 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Tremor (shakiness) | 0.037 scores on a scale | Standard Error 0.0555 |
| Neurontin® (Gabapentin) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Energy Level (get up and go) | 0.256 scores on a scale | Standard Error 0.1743 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Sleepiness (fatigue, sedation, tiredness) | 1.176 scores on a scale | Standard Error 0.2843 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Moodiness | 0.098 scores on a scale | Standard Error 0.1155 |
| Placebo | 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 | 0.125 scores on a scale | Standard Error 0.146 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Attention Span | 0.146 scores on a scale | Standard Error 0.1085 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Motivation | 0.368 scores on a scale | Standard Error 0.1309 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Walking (balance) | 0.405 scores on a scale | Standard Error 0.1206 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Vision (blurring, double vision) | 0.249 scores on a scale | Standard Error 0.1249 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Interest (in activities) | 0.096 scores on a scale | Standard Error 0.1145 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Alertness | 0.607 scores on a scale | Standard Error 0.1809 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Coordination | 0.350 scores on a scale | Standard Error 0.1306 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Tremor (shakiness) | -0.031 scores on a scale | Standard Error 0.0556 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Concentration (ability to concentrate on a task) | 0.137 scores on a scale | Standard Error 0.1166 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Energy Level (get up and go) | 0.315 scores on a scale | Standard Error 0.1766 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Speech (slurring words) | 0.065 scores on a scale | Standard Error 0.0501 |
| Placebo | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Forgetfulness | 0.175 scores on a scale | Standard Error 0.1098 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Motivation | 0.271 scores on a scale | Standard Error 0.1309 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Moodiness | 0.100 scores on a scale | Standard Error 0.1155 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Vision (blurring, double vision) | 0.115 scores on a scale | Standard Error 0.1249 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Energy Level (get up and go) | 0.331 scores on a scale | Standard Error 0.1766 |
| Placebo (Sugar Pill) | 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 | -0.041 scores on a scale | Standard Error 0.146 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Walking (balance) | 0.107 scores on a scale | Standard Error 0.1206 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Interest (in activities) | 0.070 scores on a scale | Standard Error 0.1145 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Coordination | 0.218 scores on a scale | Standard Error 0.1306 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Tremor (shakiness) | 0.068 scores on a scale | Standard Error 0.0556 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Concentration (ability to concentrate on a task) | 0.182 scores on a scale | Standard Error 0.1166 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Speech (slurring words) | 0.103 scores on a scale | Standard Error 0.0501 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Forgetfulness | 0.079 scores on a scale | Standard Error 0.1099 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Sleepiness (fatigue, sedation, tiredness) | 0.541 scores on a scale | Standard Error 0.2844 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Alertness | 0.353 scores on a scale | Standard Error 0.1809 |
| Placebo (Sugar Pill) | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). | Attention Span | 0.015 scores on a scale | Standard Error 0.1085 |
Comparison: Visionp-value: 0.017795% CI: [-0.521, -0.051]ANOVA
Comparison: Energy Levelp-value: 0.41295% CI: [-0.536, 0.222]ANOVA
Comparison: Memoryp-value: 0.772495% CI: [-0.362, 0.27]ANOVA
Comparison: Walking Balancep-value: 0.425595% CI: [-0.423, 0.18]ANOVA
Comparison: Interest in activitiesp-value: 0.892595% CI: [-0.229, 0.262]ANOVA
Comparison: Coordinationp-value: 0.129395% CI: [-0.487, 0.063]ANOVA
Comparison: Tremorp-value: 0.030495% CI: [-0.266, -0.014]ANOVA
Comparison: Concentrationp-value: 0.581195% CI: [-0.384, 0.217]ANOVA
Comparison: Speechp-value: 0.114495% CI: [-0.22, 0.024]ANOVA
Comparison: Forgetfulnessp-value: 0.377495% CI: [-0.352, 0.135]ANOVA
Comparison: Sleepinessp-value: 0.865895% CI: [-0.613, 0.727]ANOVA
Comparison: Moodinessp-value: 0.854395% CI: [-0.179, 0.216]ANOVA
Comparison: Alertnessp-value: 0.429495% CI: [-0.537, 0.231]ANOVA
Comparison: Attention Spanp-value: 0.361395% CI: [-0.357, 0.132]ANOVA
Comparison: Motivationp-value: 0.720195% CI: [-0.305, 0.212]ANOVA
Comparison: Visionp-value: 0.076795% CI: [-0.448, 0.023]ANOVA
Comparison: Energy Levelp-value: 0.261895% CI: [-0.597, 0.165]ANOVA
Comparison: Memoryp-value: 0.763395% CI: [-0.366, 0.269]ANOVA
Comparison: Walking Balancep-value: 0.196895% CI: [-0.502, 0.105]ANOVA
Comparison: Interest in Activitiesp-value: 0.689195% CI: [-0.296, 0.197]ANOVA
Comparison: Coordinationp-value: 0.222995% CI: [-0.447, 0.106]ANOVA
Comparison: Tremorp-value: 0.259195% CI: [-0.197, 0.054]ANOVA
Comparison: Concentrationp-value: 0.709995% CI: [-0.359, 0.246]ANOVA
Comparison: Speechp-value: 0.621595% CI: [-0.154, 0.092]ANOVA
Comparison: Forgetfulnessp-value: 0.642295% CI: [-0.302, 0.187]ANOVA
Comparison: Sleepinessp-value: 0.157495% CI: [-1.157, 0.19]ANOVA
Comparison: Moodinessp-value: 0.403995% CI: [-0.115, 0.282]ANOVA
Comparison: Alertnessp-value: 0.114595% CI: [-0.695, 0.076]ANOVA
Comparison: Attention Spanp-value: 0.308395% CI: [-0.372, 0.119]ANOVA
Comparison: Motivationp-value: 0.163895% CI: [-0.443, 0.0776]ANOVA
Comparison: Visionp-value: 0.510195% CI: [-0.314, 0.157]ANOVA
Comparison: Energy Levelp-value: 0.228595% CI: [-0.614, 0.149]ANOVA
Comparison: Memoryp-value: 0.461295% CI: [-0.2, 0.436]ANOVA
Comparison: Walking Balancep-value: 0.51995% CI: [-0.205, 0.402]ANOVA
Comparison: Interest in Activitiesp-value: 0.847995% CI: [-0.271, 0.223]ANOVA
Comparison: Coordinationp-value: 0.780895% CI: [-0.316, 0.238]ANOVA
Comparison: Tremorp-value: 0.008395% CI: [-0.296, -0.045]ANOVA
Comparison: Concentrationp-value: 0.506895% CI: [-0.404, 0.201]ANOVA
Comparison: Speechp-value: 0.272595% CI: [-0.191, 0.055]ANOVA
Comparison: Forgetfulnessp-value: 0.749895% CI: [-0.206, 0.284]ANOVA
Comparison: Sleepinessp-value: 0.655495% CI: [-0.522, 0.826]ANOVA
Comparison: Moodinessp-value: 0.414395% CI: [-0.116, 0.28]ANOVA
Comparison: Alertnessp-value: 0.776195% CI: [-0.441, 0.33]ANOVA
Comparison: Attention Spanp-value: 0.969795% CI: [-0.241, 0.251]ANOVA
Comparison: Motivationp-value: 0.511895% CI: [-0.346, 0.174]ANOVA
Secondary
Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
Miles per Hour (mph)
Time frame: Baseline and Hour 3 on Day 3
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | 0.831 mph | Standard Error 0.4844 |
| Neurontin® (Gabapentin) | Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | 0.947 mph | Standard Error 0.4648 |
| Placebo | Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). | 0.851 mph | Standard Error 0.4715 |
p-value: 0.829395% CI: [-1.178, 0.947]ANOVA
p-value: 0.970595% CI: [-1.089, 1.049]ANOVA
Secondary
Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator 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.
Time frame: Baseline and Hour 3 on Day 3
Population: The above is a Secondary Outcome Measure (comparing the SDLP between Gralise® and Lyrica®).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gralise® (Gabapentin) | 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 |
| Neurontin® (Gabapentin) | Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® | 0.356 feet | Standard Error 0.077 |
| Placebo | Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® | 0.135 feet | Standard Error 0.077 |
p-value: 0.110395% CI: [-0.227, 0.024]ANOVA
p-value: 0.061195% CI: [-0.006, 0.245]ANOVA
Secondary
To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.
* 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)
Time frame: Screening to 1 week after Period 4 discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gralise® (Gabapentin) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with TEAE | 6 participants |
| Gralise® (Gabapentin) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects Discontinued due to AE | 0 participants |
| Gralise® (Gabapentin) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with SAE | 0 participants |
| Neurontin® (Gabapentin) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with TEAE | 13 participants |
| Neurontin® (Gabapentin) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects Discontinued due to AE | 1 participants |
| Neurontin® (Gabapentin) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with SAE | 0 participants |
| Placebo | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with SAE | 0 participants |
| Placebo | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with TEAE | 16 participants |
| Placebo | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects Discontinued due to AE | 1 participants |
| Placebo (Sugar Pill) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with TEAE | 5 participants |
| Placebo (Sugar Pill) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects Discontinued due to AE | 0 participants |
| Placebo (Sugar Pill) | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. | Subjects with SAE | 0 participants |