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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00078312 | Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder | PHASE3 | COMPLETED | 328 | — | — | Jan 1, 2004 | Jul 1, 2006 | Jul 19, 2013 | 50 | United States, Russia |
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.
| Name | Type | Description |
|---|---|---|
| CEP-10953 (Armodafinil) | DRUG | Armodafinil (po) 100 to 250 mg/day up to 12 months |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: 1. Written informed consent is obtained. 2. Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible. 3. The patient has a complaint of excessive sleepi...