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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.
Sponsor:
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00078377
First received: February 24, 2004
Last updated: December 17, 2009
Last verified: December 2009
History of Changes
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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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 ]
  Show Outcome Measure 1

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 ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
Measure Description Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
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 (received at least 1 dose of study drug): 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 analysis.

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 Clinical Global Impression of Change (CGI-C) Score at 12 Weeks  
[units: Participants]
 		  60     58     58     118  


Statistical Analysis 1 for Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
Groups [1] Placebo vs. Armodafinil Combined Group (250 mg/Day and 150 mg/Day)
Method [2] Cochran-Mantel-Haenszel
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[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.




  Serious Adverse Events
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  Other Adverse Events
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  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: December 17, 2009
Health Authority: United States: Food and Drug Administration