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An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00678691
First received: May 13, 2008
Last updated: December 9, 2014
Last verified: December 2014
Results First Received: September 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia, Primary
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
Subjects were easily recruited and screened for study entry

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were exluded after informed consent if medical confounding variables or safety variables were found

Reporting Groups
  Description
A,1 Armodafinil Study Drug 50-250mg Flexible Dose armodafinil
A,2 Matching Placebo placebo

Participant Flow:   Overall Study
    A,1 Armodafinil Study Drug 50-250mg Flexible Dose   A,2 Matching Placebo
STARTED   27   28 
COMPLETED   21   24 
NOT COMPLETED   6   4 
Adverse Event                6                4 



  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
A,1 Armodafinil Study Drug armodafinil
A,2 Matching Placebo placebo
Total Total of all reporting groups

Baseline Measures
   A,1 Armodafinil Study Drug   A,2 Matching Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   28   55 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   27   28   55 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (4)   47  (4)   49  (4) 
Gender 
[Units: Participants]
     
Female   25   25   50 
Male   2   3   5 
Region of Enrollment 
[Units: Participants]
     
United States   27   28   55 


  Outcome Measures

1.  Primary:   Brief Fatigue Inventory   [ Time Frame: 8 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Thomas Schwartz
Organization: SUNY Upstate Medical University
phone: 3154643166
e-mail: schwartt@upstate.edu



Responsible Party: Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00678691     History of Changes
Obsolete Identifiers: NCT00568919
Other Study ID Numbers: ArmoFibro-001
Study First Received: May 13, 2008
Results First Received: September 6, 2012
Last Updated: December 9, 2014