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
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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 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  
Number of Participants  
[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  
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  
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  
[1] 2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)



  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 ]
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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  
Safety Issue No  

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)  
Number of 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
Method [2] ANCOVA
P Value [3] 0.0024
Mean Difference (Final Values) [4] 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] Other relevant method information, such as adjustments or degrees of freedom:
  The corresponding baseline value as a covariate.
[3] 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.
[4] 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


  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