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Armodafinil 100 to/day · 1 trial · 4 indications
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Armodafinil 100 to 250 mg/day |
| Name | Type | Description |
|---|---|---|
| Armodafinil 100 to 250 mg/day | DRUG | Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD). |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible. * The patient has completed a cephalo...
Armodafinil 100 to/day is being studied for excessive daytime sleepiness, a neurological condition marked by an inability to stay awake during the day. The clinical program also enrolled patients with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and chronic shift work sleep disorder, all of which can cause excessive sleepiness.
Armodafinil 100 to/day targets SLC6A3, also known as the dopamine transporter. It acts as an inhibitor of this target. By inhibiting SLC6A3, the drug is designed to modulate dopamine signaling, which is the proposed mechanism underlying its effect on excessive daytime sleepiness.
Armodafinil 100 to/day is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor responsible for the clinical development of this small molecule candidate for excessive daytime sleepiness.
Armodafinil 100 to/day is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA for the studied indication. The Phase 3 program has completed, with no active trials currently listed.
Armodafinil 100 to/day has been evaluated in one completed Phase 3 trial, NCT00228553, titled an extension study of the safety and efficacy of armodafinil in the treatment of patients with excessive sleepiness. That trial enrolled 743 participants across the United States, Australia, Canada, France, Germany, Puerto Rico, and Russia.