Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial

Frederick Vinckenbosch; Gert Jan Lammers; Sebastiaan Overeem; Dan Chen; Grace Wang; Lawrence P Carter; Kefei Zhou; Johannes G Ramaekers; Annemiek Vermeeren

doi:10.1002/hup.2858

Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial

Frederick Vinckenbosch (Corresponding author), Gert Jan Lammers, Sebastiaan Overeem, Dan Chen, Grace Wang, Lawrence P Carter, Kefei Zhou, Johannes G Ramaekers, Annemiek Vermeeren

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Onderzoeksoutput: Bijdrage aan tijdschrift › Tijdschriftartikel › Academic › peer review

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OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.

METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.

RESULTS: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence.

CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.

Originele taal-2	Engels
Artikelnummer	e2858
Aantal pagina's	10
Tijdschrift	Human Psychopharmacology
Volume	38
Nummer van het tijdschrift	1
Vroegere onlinedatum	24 nov. 2022
DOI's	https://doi.org/10.1002/hup.2858
Status	Gepubliceerd - jan. 2023

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title = "Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial",

abstract = "OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.RESULTS: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence.CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.",

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author = "Frederick Vinckenbosch and Lammers, {Gert Jan} and Sebastiaan Overeem and Dan Chen and Grace Wang and Carter, {Lawrence P} and Kefei Zhou and Ramaekers, {Johannes G} and Annemiek Vermeeren",

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AU - Chen, Dan

AU - Wang, Grace

AU - Carter, Lawrence P

AU - Zhou, Kefei

AU - Ramaekers, Johannes G

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AB - OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving performance in participants with narcolepsy.METHODS: In this randomised, double-blind, placebo-controlled, crossover study, driving performance during a 1 h on-road driving test was assessed at 2 and 6 h post-dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post-dose.RESULTS: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post-dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, -1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post-dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, -1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence.CONCLUSIONS: Solriamfetol 300 mg/day improved on-the-road driving performance, at 2 h post-administration in participants with narcolepsy.

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KW - Phenylalanine/therapeutic use

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Effects of solriamfetol on on-the-road driving in participants with narcolepsy: A randomised crossover trial

Samenvatting

Bibliografische nota

Duurzame ontwikkelingsdoelstellingen van de VN

Toegang tot document

Andere bestanden en links

Vingerafdruk

Impact

Sleep Medicine

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