Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00236080
First received: October 7, 2005
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: June 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Chronic Shift Work Sleep Disorder
Interventions: Drug: PROVIGIL 200 mg
Drug: Armodafinil 250 mg
Drug: Armodafinil 200 mg
Drug: Armodafinil 150 mg
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
16 centers in the US. First participant enrolled: 7 September 2005/ Last participant last visit: 1 December 2005

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)

Reporting Groups
  Description
PROVIGIL 200 mg/Day PROVIGIL 200 mg once daily only on nights worked
Armodafinil 250 mg/Day Armodafinil 250 mg once daily only on nights worked
Armodafinil 200 mg/Day Armodafinil 200 mg once daily only on nights worked
Armodafinil 150 mg/Day Armodafinil 150 mg once daily only on nights worked
Placebo Matching placebo tablets once daily only on nights worked

Participant Flow:   Overall Study
    PROVIGIL 200 mg/Day     Armodafinil 250 mg/Day     Armodafinil 200 mg/Day     Armodafinil 150 mg/Day     Placebo  
STARTED     29     28     27     25     27  
COMPLETED     27     27     22     23     26  
NOT COMPLETED     2     1     5     2     1  
Adverse Event                 0                 0                 3                 1                 0  
Lost to Follow-up                 0                 1                 0                 0                 0  
Physician Decision                 1                 0                 1                 1                 1  
Withdrawal by Subject                 1                 0                 0                 0                 0  
Miscellaneous                 0                 0                 1                 0                 0  



  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
PROVIGIL 200 mg/Day PROVIGIL 200 mg once daily only on nights worked
Armodafinil 250 mg/Day Armodafinil 250 mg once daily only on nights worked
Armodafinil 200 mg/Day Armodafinil 200 mg once daily only on nights worked
Armodafinil 150 mg/Day Armodafinil 150 mg once daily only on nights worked
Placebo Matching placebo tablets once daily only on nights worked
Total Total of all reporting groups

Baseline Measures
    PROVIGIL 200 mg/Day     Armodafinil 250 mg/Day     Armodafinil 200 mg/Day     Armodafinil 150 mg/Day     Placebo     Total  
Number of Participants  
[units: participants]
  29     28     27     25     27     136  
Age [1]
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     29     28     26     25     26     134  
>=65 years     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.8  ± 8.92     34.3  ± 9.87     34.5  ± 7.60     38.3  ± 12.83     38.0  ± 9.83     36.3  ± 9.90  
Gender [1]
[units: participants]
           
Female     18     12     13     8     6     57  
Male     11     16     13     17     20     77  
Region of Enrollment [1]
[units: participants]
           
United States     29     28     26     25     26     134  
[1] 2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Multiple Sleep Latency Test (MSLT)   [ Time Frame: Endpoint (Visit 4) change from baseline (Visit 2) ]

2.  Primary:   Psychomotor Vigilance Task (PVT)   [ Time Frame: Endpoint (Visit 4) change from baseline (Visit 2) ]


  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
In analyzing the PVT data, it was discovered that data transfer errors had occurred at certain study centers. The ability to interpret the efficacy results from this study is limited, and the findings should be considered inconclusive.


  More Information
  Hide More Information

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: Sponsor's Medical Director, Clinical Research
Organization: Cephalon, Inc.
phone: 1-877-237-4879


No publications provided


Responsible Party: Sponsor's Medical Expert, Cephalon
ClinicalTrials.gov Identifier: NCT00236080     History of Changes
Other Study ID Numbers: C10953/3045/CM/US
Study First Received: October 7, 2005
Results First Received: June 1, 2009
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration