5 results
To evaluate the safety and tolerability of JZP-110 administered once daily for up to 52 weeks in doses of 75, 150, and 300 mg
To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 37.5, 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy.
To investigate whether mifepristone (7-day, 1200 mg/day) added to treatment as usual (TAU), is more efficacious than placebo in reducing depressive symptom severity (Inventory of Depressive Symptoms-Self Rated questionnaire; IDS-SR) in patients with…