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Also known as modafinil
PROVIGIL · 9 trials · 6 indications
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.
Evaluate the safety and tolerability of treatment in children and adolescents with excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome, when administered for up to 6 months
| 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 |
| Modafinil | EXPERIMENTAL | Subjects began taking Provigil at a dosage of 100 mg/day (1 tablet) and increased their dosage by 100 mg/day each week for up to 4 weeks |
| Name | Type | Description |
|---|---|---|
| Modafinil | DRUG | - |
| 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: * Written informed consent/assent is obtained. * The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-sp...
PROVIGIL is being studied for chronic shift work sleep disorder, a condition affecting people who work non-traditional hours. The clinical program in this indication is a Phase 3 trial conducted in the United States. PROVIGIL is a small molecule therapeutic developed by Teva Pharmaceutical Industries Limited.
PROVIGIL is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating PROVIGIL in chronic shift work sleep disorder.
PROVIGIL is in Phase 3 clinical development for chronic shift work sleep disorder. The program includes one completed Phase 3 trial with 136 enrolled participants. No active trials are currently listed for this indication.
PROVIGIL has been evaluated in the Phase 3 trial NCT00236080, titled Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL. The trial enrolled 136 participants in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.