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Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01080807
First received: March 3, 2010
Last updated: May 17, 2012
Last verified: May 2012
Results First Received: October 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Excessive Sleepiness
Interventions: Drug: Armodafinil
Drug: Matching 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
385 patients at 45 centers in the US met entry criteria and were considered eligible for enrollment into the study; 2 of these patients enrolled twice under different identification numbers. Of the 383 patients enrolled, 371 received at least 1 dose of study drug and were evaluated for safety; 12 patients withdrew before taking any study drug.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 1- to 3-week screening period, a 1-week baseline period (followed by randomization), and a 6-week double-blind treatment period.

Reporting Groups
  Description
150 mg/Day Armodafinil At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Matching Placebo At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.

Participant Flow:   Overall Study
    150 mg/Day Armodafinil     Matching Placebo  
STARTED     193 [1]   190 [2]
COMPLETED     158     167  
NOT COMPLETED     35     23  
Adverse Event                 9                 1  
Lack of Efficacy                 0                 1  
Withdrawal by Subject                 7                 2  
Protocol Violation                 7                 6  
Lost to Follow-up                 6                 4  
Noncompliance with drug administration                 1                 1  
Noncompliance to study procedures                 1                 1  
Began working day shift                 0                 2  
Laid off or terminated from job                 1                 2  
Stopped working consistent night shifts                 0                 1  
Work schedule changing                 1                 1  
Work schedule and travel                 0                 1  
Switched to first shift                 1                 0  
Moved away without notifying center                 1                 0  
[1] Nine patients randomly assigned to the armodafinil treatment group did not receive study drug.
[2] Three patients randomly assigned to the placebo treatment group did not receive study drug.



  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
150 mg/Day Armodafinil At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Matching Placebo At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Total Total of all reporting groups

Baseline Measures
    150 mg/Day Armodafinil     Matching Placebo     Total  
Number of Participants  
[units: participants]
  193     190     383  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     193     190     383  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.7  ± 10.71     36.1  ± 10.75     36.4  ± 10.72  
Gender  
[units: participants]
     
Female     85     90     175  
Male     108     100     208  
Region of Enrollment  
[units: participants]
     
United States     193     190     383  



  Outcome Measures
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1.  Primary:   Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

2.  Secondary:   Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

3.  Secondary:   Change From Baseline to Week 3 in Global Assessment of Functioning   [ Time Frame: Baseline and Week 3 ]

4.  Secondary:   Change From Baseline to Week 6 in Global Assessment of Functioning   [ Time Frame: Baseline and Week 6 ]

5.  Secondary:   Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

6.  Secondary:   Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score   [ Time Frame: Baseline and week 3 ]

7.  Secondary:   Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score   [ Time Frame: Baseline and week 6 ]

8.  Secondary:   Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3   [ Time Frame: Baseline and week 3 ]

9.  Secondary:   Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6   [ Time Frame: Baseline and week 6 ]

10.  Secondary:   Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

11.  Secondary:   Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

12.  Secondary:   Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score   [ Time Frame: Baseline and week 6 (or last observation (or last observation after baseline)) ]

13.  Secondary:   Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

14.  Secondary:   Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

15.  Secondary:   Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

16.  Secondary:   Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint   [ Time Frame: Endpoint ]

17.  Secondary:   Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint   [ Time Frame: Endpoint ]

18.  Secondary:   Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint   [ Time Frame: Endpoint ]

19.  Secondary:   Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint   [ Time Frame: Endpoint ]

20.  Secondary:   Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

21.  Secondary:   Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

22.  Secondary:   Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

23.  Secondary:   Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

24.  Secondary:   Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]

25.  Secondary:   Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy   [ Time Frame: Baseline and week 6 (or last observation after baseline) ]


  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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  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.


Results Point of Contact:  
Name/Title: Vice President, Medical Affairs
Organization: Cephalon, Inc.
phone: 610-727-6353


No publications provided by Teva Pharmaceutical Industries

Publications automatically indexed to this study:

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01080807     History of Changes
Other Study ID Numbers: C10953/4030
Study First Received: March 3, 2010
Results First Received: October 21, 2011
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration