Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
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|ClinicalTrials.gov Identifier: NCT00228553|
Recruitment Status : Completed
First Posted : September 29, 2005
Results First Posted : March 31, 2010
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Chronic Shift Work Sleep Disorder||Drug: Armodafinil 100 to 250 mg/day||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||743 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||July 2006|
Armodafinil 100 to 250 mg/day
Drug: Armodafinil 100 to 250 mg/day
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).
- Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) [ Time Frame: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228553
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|Study Director:||Sponsor's Medical Director, MD||Cephalon|