Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00596466
First received: January 8, 2008
Last updated: August 10, 2012
Last verified: August 2012
Results First Received: June 22, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: pregabalin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).

Reporting Groups
  Description
Pregabalin Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     75  
Enrolled, Treated     73  
COMPLETED     58  
NOT COMPLETED     17  
Lack of Efficacy                 5  
Adverse Event                 4  
Withdrawal by Subject                 2  
Protocol Violation                 2  
Unpecified                 2  
Enrolled, not treated                 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 Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  75  
Age, Customized  
[units: Participants]
 
18-44 years     48  
45-64 years     23  
Greater than or equal to (≥) 65 years     4  
Gender  
[units: Participants]
 
Female     38  
Male     37  



  Outcome Measures
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1.  Primary:   Seizure Frequency   [ Time Frame: Baseline up to Week 28 ]

2.  Primary:   Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 28 ]

3.  Primary:   Number of Participants With Laboratory Test Values of Potential Clinical Importance   [ Time Frame: Baseline up to Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00596466     History of Changes
Other Study ID Numbers: A0081160
Study First Received: January 8, 2008
Results First Received: June 22, 2012
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration