Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Armodafinil/day · 2 trials · 3 indications
The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Armodafinil 250 mg/day |
| 2 | EXPERIMENTAL | Armodafinil 150 mg/day |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Armodafinil 250 mg/day | DRUG | Armodafinil 250 mg once daily in the morning |
| Armodafinil 150 mg/day | DRUG | Armodafinil 150 mg once daily in the morning |
| Placebo | DRUG | Matching placebo tablets once daily in the morning |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: 1. Written informed consent is obtained. 2. The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). 3. The patient has a complaint of excessive sleepiness de...
Armodafinil is an investigational small molecule being studied for use in bipolar I depression, obstructive sleep apnea, excessive sleepiness, schizophrenia, depression, and excessive daytime sleepiness. It is being developed by Teva Pharmaceutical Industries Limited (TEVA) and is currently in Phase 2 clinical development.
Armodafinil is a small molecule that targets the central nervous system to promote wakefulness. It is being studied for its effects on excessive sleepiness associated with conditions like obstructive sleep apnea and as an adjunctive treatment for depression in bipolar I disorder.
Armodafinil is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 2 clinical trials for psychiatric and sleep-related indications.
Armodafinil is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for conditions such as obstructive sleep apnea and bipolar I depression, but the drug remains under investigation.
Armodafinil has been studied in several completed clinical trials, including NCT00078325 for excessive sleepiness in obstructive sleep apnea, and NCT01072630, NCT01072929, and NCT01305408 for adjunctive treatment of major depression in bipolar I disorder. These trials were randomized, double-blind, and placebo-controlled.
Armodafinil is the generic name for the drug marketed as Nuvigil. It is the longer-acting enantiomer of modafinil and is used to improve wakefulness in patients with excessive sleepiness associated with conditions like obstructive sleep apnea.