Pain management · 2018
Effects of gabapentin, pregabalin and gastroretentive gabapentin on simulated driving, daytime sedation and cognition.
Клиническое исследование I фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Schmidt Peter, Rao Srinivas
Аннотация
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.
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.