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Also known as Provigil
modafinil · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
Modafinil is a small molecule drug developed by Teva Pharmaceutical Industries Limited for psychiatric and sleep-related conditions. It is being studied in Phase 3 clinical development for attention deficit hyperactivity disorder (ADHD), narcolepsy, and obstructive sleep apnea. It is an investigational agent in these programs rather than a newly approved product.
Modafinil targets SLC6A3, the dopamine transporter, and acts as an inhibitor of this target. By inhibiting SLC6A3, modafinil modulates dopamine reuptake, which is the mechanism underlying its activity in ADHD and sleep-wake disorders. This target class places it among dopamine transporter inhibitors used in psychiatry.
Modafinil is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor associated with the clinical development program covering ADHD, narcolepsy, and obstructive sleep apnea indications for this small molecule asset.
Modafinil is in Phase 3 clinical development for its psychiatric and sleep-related indications. The program includes completed Phase 3 and Phase 2 trials, with no active trials currently listed. It should be described as investigational in these development programs rather than as a newly approved therapy.
Modafinil has been studied in completed trials including NCT00343811, a Phase 3 ADHD study in patients who responded to modafinil, NCT00315276, a Phase 2 dose-finding study in adults with ADHD, NCT00228540, a Phase 3 satisfaction study in children and adolescents, and NCT00214981, a Phase 3 safety and efficacy study in children and adolescents with ADHD.
Modafinil is being developed for attention deficit hyperactivity disorder, including studies in both adults and children as young as six years old. Its ADHD program spans Phase 2 dose-finding and Phase 3 efficacy and safety trials conducted in the United States, with enrollment across these completed studies totaling several hundred participants.