Clinical trial NCT03179345: Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Volunteer
Pharmacodynamics
Pharmacokinetics
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin®
timeFrame: Baseline and Hour 3 on Day 3
Secondary outcomes:
measure: Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica®
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET)
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT).
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN).
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL)
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT).
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS).
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
timeFrame: Baseline and Hour 3 on Day 3
measure: Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
timeFrame: Baseline and Hour 3 on Day 3
measure: To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.
timeFrame: Screening to 1 week after Period 4 discharge
Other outcomes:
Locations:
Study officials:
affiliation: Depomed
name: Head of R&D
role: STUDY_DIRECTOR
References:
citation: Schmidt P, Rao S. Effects of gabapentin, pregabalin and gastroretentive gabapentin on simulated driving, daytime sedation and cognition. Pain Manag. 2018 Jul 1;8(4):297-306. doi: 10.2217/pmt-2018-0005. Epub 2018 Apr 19.