Effects of Gabapentin, Pregabalin and Gastroretentive Gabapentin on Simulated Driving, Daytime Sedation and Cognition

Abstract

Aim: Randomized Phase I study examining the effects of gabapentinoids gabapentin, pregabalin and gastroretentive gabapentin on simulated driving performance, sedation and cognitive function in healthy volunteers (n = 32). Methods: Driving attentiveness, sleepiness and cognition were evaluated prior to subjects receiving study doses. Blood samples were collected during each treatment. Results: Subjects receiving gastroretentive gabapentin showed less change in variation in lateral lane position (p = 0.0275), less tremor (p = 0.0304) and fewer vision disturbances compared with gabapentin (p = 0.0177). Statistically significant decrease in One Card Learning Test performance was observed after treatment with gastroretentive gabapentin. Conclusion: Gastroretentive gabapentin demonstrated reduced driving impairment and lower scores on key neurotoxicity measures. Further studies in patients with postherpetic neuralgia are needed.

Clinical trial number: NCT03179345

Keywords::

• cognition
• driving performance
• gabapentinoids
• gastroretentive gabapentin
• postherpetic neuralgia
• sedation

Acknowledgements

Statistical analysis provided by Systems Technology, Inc., Frontage Laboratories, Inc.

Author contributions

All authors had full access to the data described herein, contributed to the interpretation of data, revised the work for important intellectual content, approved the final version of the manuscript and agree to be accountable for all aspects of the manuscript.

Financial & competing interests disclosure

P Schmidt is a former employee and shareholder of Depomed, Inc. S Rao is a former employee and shareholder of Depomed, Inc., and is a consultant for Depomed, Inc. This trial was sponsored by Depomed, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. Editorial support was provided by Michelle Jones, MedVal Scientific Information Services, LLC, and was funded by Depomed, Inc.

Ethical disclosure

The authors state that they have obtained appropriate institutional review board approval for all human experimental investigations. In addition, informed consent has been obtained from the participants involved.

Additional information

Funding

P Schmidt is a former employee and shareholder of Depomed, Inc. S Rao is a former employee and shareholder of Depomed, Inc., and is a consultant for Depomed, Inc. This trial was sponsored by Depomed, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance was utilized in the production of this manuscript. Editorial support was provided by Michelle Jones, MedVal Scientific Information Services, LLC, and was funded by Depomed, Inc.