Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PROVIGIL · 1 trial · 1 indication
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...
PROVIGIL is used for Chronic Shift Work Sleep Disorder, a condition affecting people who work during non-traditional hours. It is a small molecule being studied in a Phase 3 clinical trial to evaluate its efficacy and multiple-dose plasma concentration-time profiles in patients with this condition.
PROVIGIL is developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The drug is currently being investigated in clinical trials for Chronic Shift Work Sleep Disorder.
PROVIGIL is in Phase 3 clinical development for Chronic Shift Work Sleep Disorder. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed.
PROVIGIL is associated with one completed Phase 3 clinical trial, identified as NCT00236080. This study evaluated the efficacy and multiple-dose plasma concentration-time profiles of armodafinil and PROVIGIL in 136 participants with Chronic Shift Work Sleep Disorder in the United States.
PROVIGIL and armodafinil are distinct drugs, though they are related. The clinical trial NCT00236080 compared the efficacy and plasma concentration-time profiles of both armodafinil and PROVIGIL in patients with Chronic Shift Work Sleep Disorder, indicating they are separate investigational products.