Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Narcolepsy
Interventions: Drug: Armodafinil
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 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
Total Total of all reporting groups

Baseline Measures
   Armodafinil 250 mg/Day   Armodafinil 150 mg/Day   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   65   64   196 
Age [1] 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   66   64   63   193 
>=65 years   1   0   0   1 
[1] 2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)
Age 
[Units: Years]
Mean (Standard Deviation)
 35.0  (12.52)   40.4  (12.52)   39.2  (11.98)   38.1  (12.50) 
Gender [1] 
[Units: Participants]
       
Female   42   36   31   109 
Male   25   28   32   85 
[1] 2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)
Region of Enrollment 
[Units: Participants]
       
United States   37   37   37   111 
Canada   12   12   12   36 
France   3   3   3   9 
Germany   5   4   4   13 
Russian Federation   5   4   4   13 
Australia   5   5   4   14 


  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 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
Measure Description The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
Time Frame change from baseline at 12 weeks  

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.

Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).

Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy.


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
Armodafinil Combined Group (250 mg/Day and 150 mg/Day) No text entered.

Measured Values
   Armodafinil 250 mg/Day   Armodafinil 150 mg/Day   Placebo   Armodafinil Combined Group (250 mg/Day and 150 mg/Day) 
Participants Analyzed 
[Units: Participants]
 60   58   58   118 
Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks 
[Units: Minutes]
Mean (Standard Deviation)
 2.6  (6.24)   1.3  (6.31)   -1.9  (6.87)   1.9  (6.28) 


Statistical Analysis 1 for Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
Groups [1] Armodafinil 250 mg/Day vs. Armodafinil 150 mg/Day vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0024
Mean Difference (Final Values) [5] 3.8
95% Confidence Interval 1.02 to 4.61
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The corresponding baseline value as a covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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
  Hide 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.


  More Information