Phase 4
Completed N=32
Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
Healthy
Source: ClinicalTrials.gov NCT03179345 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® — 0.255; 0.395; 0.135 feet — p=0.0275
◆ Published Evidence
Emerging
8citations · ~1 / year
Effects of gabapentin, pregabalin and gastroretentive gabapentin on simulated driving, daytime sedation and cognition.
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.
Linked Publications
-
Effects of gabapentin, pregabalin and gastroretentive gabapentin on simulated driving, daytime sedation and cognition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® |
0.255; 0.395; 0.135 | 0.0275 sig |
| SECONDARY Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® |
0.255; 0.356; 0.135 | 0.1103 |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) |
0.00; 0.00; -0.01; -0.00 | 0.9946 |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). |
-0.40; -0.01; -0.64; 3.32 | 0.8799 |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN). |
-0.00; 0.00; -0.00; 0.01 | 0.7111 |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) |
0.36; 0.82; 0.03; -0.01 | 0.5950 |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). |
0.02; 0.06; 0.00; 0.03 | 0.0070 sig |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). |
.774; .264; .868; .264 | 0.1026 |
| SECONDARY Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). |
0.036; 0.322; 0.249; 0.115; 0.099; 0.256 | 0.0177 sig |
| SECONDARY Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). |
0.831; 0.947; 0.851 | 0.8293 |
| SECONDARY Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). |
0.831; 1.319; 0.851 | 0.3666 |
| SECONDARY To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. |
6; 13; 16; 5; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03179345) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.