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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
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;   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
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
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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

  Limitations and Caveats
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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
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