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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00078325 | Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS) | PHASE3 | COMPLETED | 395 | — | — | Feb 1, 2004 | Nov 1, 2004 | Jul 19, 2013 | - | — |
| NCT00079677 | Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome | PHASE3 | COMPLETED | 263 | — | — | Mar 1, 2004 | Oct 1, 2004 | Jul 19, 2013 | - | — |
The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Armodafinil 250 mg/day |
| 2 | EXPERIMENTAL | Armodafinil 150 mg/day |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Armodafinil 250 mg/day | DRUG | Armodafinil 250 mg once daily in the morning |
| Armodafinil 150 mg/day | DRUG | Armodafinil 150 mg once daily in the morning |
| Placebo | DRUG | Matching placebo tablets once daily in the morning |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: 1. Written informed consent is obtained. 2. The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). 3. The patient has a complaint of excessive sleepiness de...