Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
This study has been completed.
Sponsor:
Cephalon
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00080288
First received: March 25, 2004
Last updated: May 14, 2010
Last verified: May 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |
---|---|
First Received Date ICMJE | March 25, 2004 |
Last Updated Date | May 14, 2010 |
Start Date ICMJE | March 2004 |
Primary Completion Date | |
Current Primary Outcome Measures ICMJE |
|
Original Primary Outcome Measures ICMJE |
|
Change History | Complete list of historical versions of study NCT00080288 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD |
Official Title ICMJE | A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder |
Brief Summary | The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Condition ICMJE |
|
Intervention ICMJE |
|
Study Arm (s) |
|
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 254 |
Completion Date | December 2004 |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria: Patients are included in the study if all of the following criteria are met:
Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
|
Gender | Both |
Ages | 18 Years to 65 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00080288 |
Other Study ID Numbers ICMJE | C10953/3022/CM/MN |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Cephalon |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Cephalon |
Verification Date | May 2010 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |