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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00236080 | Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL | PHASE3 | COMPLETED | 136 | — | — | Aug 1, 2005 | Dec 1, 2005 | Jul 19, 2013 | 20 | United States |
The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.
The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | PROVIGIL 200 mg/day |
| 2 | EXPERIMENTAL | Armodafinil 250 mg/day |
| 3 | EXPERIMENTAL | Armodafinil 200 mg/day |
| 4 | EXPERIMENTAL | Armodafinil 150 mg/day |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PROVIGIL 200 mg | DRUG | PROVIGIL 200 mg/day |
| Armodafinil 250 mg | DRUG | Armodafinil 250 mg/day |
| Armodafinil 200 mg | DRUG | Armodafinil 200 mg/day |
| Armodafinil 150 mg | DRUG | Armodafinil 150 mg/day |
| Placebo | DRUG | Matching placebo tablets |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * The patient speaks and writes in English. * The patient is a man or woman of any ethnic origin aged 18 through 65 years. * The patient is in good health as determined by a medical and psychiatric his...