An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

This study has been terminated.
(This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00372528
First received: September 5, 2006
Last updated: September 21, 2012
Last verified: September 2012
Results First Received: September 21, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: pregabalin (LYRICA)

  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
No text entered.

Reporting Groups
  Description
Pregabalin Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     21  
COMPLETED     0  
NOT COMPLETED     21  
Lack of Efficacy                 1  
Adverse Event                 1  
Study Terminated by Sponsor                 18  
Unspecified                 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.
No text entered.

Reporting Groups
  Description
Pregabalin Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  21  
Age  
[units: Years]
Mean ± Standard Deviation
  44.0  ± 12.6  
Gender  
[units: Participants]
 
Female     12  
Male     9  
Mean Number of Seizures [1]
[units: Seizures]
Mean ± Standard Deviation
  30.70  ± 40.63  
[1] Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated from baseline visit to 1 day before Month 6 visit.



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Year 5 and follow-up (30 days after last dose) ]

2.  Secondary:   Mean Number of Seizures   [ Time Frame: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) ]


  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
This was a compassionate use study and no formal primary outcome measure was specified a priori. Descriptive safety data were collected, subsequently safety outcome was designated as primary outcome as per National Institute of Health (NIH) criteria.


  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.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00372528     History of Changes
Other Study ID Numbers: A0081140
Study First Received: September 5, 2006
Results First Received: September 21, 2012
Last Updated: September 21, 2012
Health Authority: Canada: Health Canada