Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica

Healthy Clinical Trial

Official title:

A Phase 4, Double-Blind, Placebo-Controlled, Crossover Study Comparing Simulated Driving Performance, Daytime Sedation, and Cognition in Healthy Volunteers Taking Therapeutic Doses of Gralise®, Neurontin®, or Lyrica®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179345
• Other study ID #: GRAL-PX-8401
• Status: Completed
• Phase: Phase 4
• Start date: September 24, 2015
• Est. completion date: November 20, 2015

Study information

• Verified date: April 2020
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 20, 2015
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Gabapentin

• Pregabalin

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
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	Baseline and Hour 3 on Day 3
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.	Baseline and Hour 3 on Day 3
Secondary	Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).	Miles per Hour (mph)	Baseline and Hour 3 on Day 3
Secondary	Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).	Miles per Hour (mph)	Baseline and Hour 3 on Day 3
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)	Screening to 1 week after Period 4 discharge