Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00228553 | Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness | PHASE3 | COMPLETED | 743 | — | — | May 1, 2004 | Jul 1, 2006 | Jul 19, 2013 | 100 | United States, Australia +5 |
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Armodafinil 100 to 250 mg/day |
| Name | Type | Description |
|---|---|---|
| Armodafinil 100 to 250 mg/day | DRUG | 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). |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible. * The patient has completed a cephalo...