Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00078312
First received: February 23, 2004
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: June 1, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Narcolepsy
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Shift-Work Sleep Disorder
Intervention: Drug: CEP-10953 (Armodafinil)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
41 centers (US 34, Russia 7). First patient enrolled: 30 January 2004/ Last patient last visit: 19 July 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 male participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant). These 5 patients are in the participant flow, but not in the safety data set since they did not receive study drug.

Reporting Groups
  Description
Armodafinil 100 to 250 mg/Day Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked

Participant Flow:   Overall Study
    Armodafinil 100 to 250 mg/Day  
STARTED     328  
COMPLETED     151  
NOT COMPLETED     177  
Adverse Event                 43  
Lack of Efficacy                 15  
Lost to Follow-up                 41  
Physician Decision                 9  
Protocol Violation                 3  
Withdrawal by Subject                 33  
Miscellaneous                 33  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Armodafinil 100 to 250 mg/Day Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked

Baseline Measures
    Armodafinil 100 to 250 mg/Day  
Number of Participants  
[units: participants]
  328  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     326  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  45.2  ± 11.27  
Gender [1]
[units: participants]
 
Female     111  
Male     212  
Region of Enrollment  
[units: participants]
 
United States     267  
Russian Federation     61  
[1] 5 male participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant)



  Outcome Measures

1.  Primary:   Safety and Tolerability as Measured by Number of Participants With Adverse Events   [ Time Frame: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Sponsor's Medical Director, Clinical Research
Organization: Cephalon
phone: 1-877-237-4879


No publications provided


ClinicalTrials.gov Identifier: NCT00078312     History of Changes
Other Study ID Numbers: C10953/3023/ES/MN
Study First Received: February 23, 2004
Results First Received: June 1, 2009
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration