Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00711516
First received: July 8, 2008
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: September 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Excessive Sleepiness
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Armodafinil (200 mg/Day) Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Placebo Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.

Participant Flow:   Overall Study
    Armodafinil (200 mg/Day)     Placebo  
STARTED     21     19  
COMPLETED     20     16  
NOT COMPLETED     1     3  
Adverse Event                 1                 1  
Withdrawal by Subject                 0                 1  
Protocol Violation                 0                 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.
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Reporting Groups
  Description
Armodafinil (200 mg/Day) Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Placebo Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Total Total of all reporting groups

Baseline Measures
    Armodafinil (200 mg/Day)     Placebo     Total  
Number of Participants  
[units: participants]
  21     19     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     19     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49.9  ± 8.98     50.7  ± 7.95     50.3  ± 8.41  
Gender  
[units: participants]
     
Female     4     5     9  
Male     17     14     31  
Region of Enrollment  
[units: participants]
     
United States     21     19     40  



  Outcome Measures
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1.  Primary:   Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

2.  Secondary:   Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

3.  Secondary:   Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

4.  Secondary:   Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

5.  Secondary:   Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

6.  Secondary:   Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

7.  Secondary:   Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

8.  Secondary:   Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

9.  Secondary:   Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

10.  Secondary:   One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

11.  Secondary:   One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

12.  Secondary:   One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

13.  Secondary:   One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

14.  Secondary:   Epworth Sleepiness Scale Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

15.  Secondary:   Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

16.  Secondary:   Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

17.  Secondary:   Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

18.  Secondary:   Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

19.  Secondary:   Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

20.  Secondary:   Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

21.  Secondary:   Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint   [ Time Frame: Endpoint (Week 2 or last observation after baseline) ]

22.  Secondary:   Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

23.  Secondary:   Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

24.  Secondary:   Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

25.  Secondary:   Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

26.  Secondary:   Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

27.  Secondary:   Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

28.  Secondary:   Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

29.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

30.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

31.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

32.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

33.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

34.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

35.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

36.  Secondary:   Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

37.  Secondary:   Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

38.  Secondary:   Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

39.  Secondary:   Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

40.  Secondary:   Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

41.  Secondary:   Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

42.  Secondary:   Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

43.  Secondary:   Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

44.  Secondary:   Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

45.  Secondary:   Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test   [ Time Frame: Baseline and Endpoint (Week 2 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sponsor's Medical Expert, Clinical Research
Organization: Cephalon, Inc.
phone: 1-800-896-5855


No publications provided by Teva Pharmaceutical Industries

Publications automatically indexed to this study:

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00711516     History of Changes
Other Study ID Numbers: C10953/4026/AP/US
Study First Received: July 8, 2008
Results First Received: September 30, 2010
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration