Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CEP-10953 · 1 trial · 4 indications
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.
| Name | Type | Description |
|---|---|---|
| CEP-10953 (Armodafinil) | DRUG | Armodafinil (po) 100 to 250 mg/day up to 12 months |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: 1. Written informed consent is obtained. 2. Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible. 3. The patient has a complaint of excessive sleepi...
CEP-10953 is an investigational small molecule being studied for the treatment of narcolepsy. It is in Phase 3 clinical development for this indication. The drug is being developed by Teva Pharmaceutical Industries Limited (TEVA).
CEP-10953 is a small molecule being studied for narcolepsy. Its specific molecular target has not been disclosed in the available information. The drug is in Phase 3 clinical development for this indication.
CEP-10953 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The drug is a small molecule in Phase 3 clinical development for the treatment of narcolepsy.
CEP-10953 is in Phase 3 clinical development for narcolepsy. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed for this indication.
CEP-10953 has one completed Phase 3 trial, NCT00078312, which enrolled 328 participants. The trial studied the drug for narcolepsy, obstructive sleep apnea/hypopnea syndrome, and chronic shift work sleep disorder in the United States and Russia.
CEP-10953 is also known as armodafinil. The completed Phase 3 trial NCT00078312 was titled 'Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder.'