Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00684424
First received: May 22, 2008
Last updated: May 27, 2010
Last verified: May 2010
Results First Received: March 9, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition: Epilepsy
Intervention: Other: Non-Interventional Study

  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 recruited from 36 medical centers and participated in the study between 11 July 2008 and 30 March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pregabalin (Lyrica) Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.

Participant Flow:   Overall Study
    Pregabalin (Lyrica)  
STARTED     199  
COMPLETED     194  
NOT COMPLETED     5  
Adverse Event                 1  
Lost to Follow-up                 2  
Not Specified                 2  



  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
Pregabalin (Lyrica) Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.

Baseline Measures
    Pregabalin (Lyrica)  
Number of Participants  
[units: participants]
  199  
Age, Customized  
[units: participants]
 
<=18 years     2  
18 - 44 years     104  
45 - 65 years     60  
>= 65 years     33  
Gender  
[units: participants]
 
Female     107  
Male     92  



  Outcome Measures
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1.  Primary:   Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency   [ Time Frame: Baseline through Week 16 ]

2.  Secondary:   Antiepileptic Drugs Used in the Past   [ Time Frame: Baseline ]

3.  Secondary:   Change in 28 Day Partial Seizure Frequency   [ Time Frame: Baseline through Week 16 (Final Visit ) ]

4.  Secondary:   Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study   [ Time Frame: Week 8 up to Week 16 (Last 4 weeks of the treatment period) ]

5.  Secondary:   Concomitant Drug Treatments   [ Time Frame: Baseline through Week 16 (Final Visit) ]

6.  Secondary:   Average Dosage of Pregabalin Taken at Baseline and Final Visit   [ Time Frame: Baseline, Week 16 (Final Visit ) ]

7.  Secondary:   Visual Analog Scale of Anxiety (VAS-A)   [ Time Frame: Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward ]

8.  Secondary:   Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)   [ Time Frame: Baseline, Week 16 (Final Visit), Last Observation Carried Forward ]

9.  Secondary:   Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)   [ Time Frame: Baseline ]

10.  Secondary:   Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)   [ Time Frame: Week 16 (Final Visit) ]

11.  Secondary:   Medical Outcomes Sleep Scale (MOS-S)   [ Time Frame: Baseline, Week 16 (Final Visit ) ]

12.  Secondary:   Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale   [ Time Frame: Baseline, Week 16 (Final Visit) ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00684424     History of Changes
Other Study ID Numbers: A0081213
Study First Received: May 22, 2008
Results First Received: March 9, 2010
Last Updated: May 27, 2010
Health Authority: Czech Republic: State Institute for Drug Control