Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00078377
First received: February 24, 2004
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: June 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Narcolepsy
Interventions: Drug: Armodafinil
Drug: Placebo

  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
47 centers in the US, Canada, France, Germany, Russia, and Australia. First patient enrolled (treatment): 23 March 2004/ Last patient last visit: 10 January 2005

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)

Reporting Groups
  Description
Armodafinil 250 mg/Day Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg/Day Armodafinil 150 mg once daily in the morning
Placebo Matching placebo tablets once daily in the morning

Participant Flow:   Overall Study
    Armodafinil 250 mg/Day     Armodafinil 150 mg/Day     Placebo  
STARTED     67     65     64  
COMPLETED     56     49     55  
NOT COMPLETED     11     16     9  
Adverse Event                 2                 5                 1  
Lack of Efficacy                 2                 0                 2  
Lost to Follow-up                 0                 1                 1  
Physician Decision                 2                 0                 0  
Withdrawal by Subject                 3                 4                 4  
Miscellaneous                 2                 6                 1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks   [ Time Frame: change from baseline at 12 weeks ]

2.  Primary:   Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks   [ Time Frame: change from baseline at 12 weeks ]


  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, Inc.
phone: 1-877-237-4879


No publications provided


ClinicalTrials.gov Identifier: NCT00078377     History of Changes
Other Study ID Numbers: C10953/3020/NA/MN
Study First Received: February 24, 2004
Results First Received: June 1, 2009
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration