Conditions: Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Chronic Shift Work Sleep Disorder
Allocation: NON_RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 743
Healthy volunteers: no

Brief summary:
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Detailed description:

Arms:
arm 1: Armodafinil 100 to 250 mg/day

Interventions: intervention 1: Armodafinil 100 to 250 mg/day
Intervention descriptions: intervention 1: Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).

Protocol document: