A randomized study of solriamfetol for excessive sleepiness in narcolepsy.

ABSTRACT:

Objective

Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. This phase 3 study (NCT02348593) evaluated the safety and efficacy of solriamfetol in narcolepsy.

Methods

Patients with narcolepsy with mean sleep latency <25 minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score ≥10, and usual nightly sleep ≥6 hours were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Coprimary endpoints were change from baseline to week 12 in MWT and ESS. Improvement on the Patient Global Impression of Change (PGI-C) was the key secondary endpoint.

Results

Safety and modified intention-to-treat populations included 236 and 231 patients, respectively. Solriamfetol 300

SUBMITTER: Thorpy MJ 

PROVIDER: S-EPMC6593450 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature