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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372528
Recruitment Status : 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.)
First Posted : September 7, 2006
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):

September 5, 2006
September 7, 2006
September 21, 2012
October 23, 2012
October 23, 2012
March 2007
October 2011   (Final data collection date for primary outcome measure)
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) ]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
  • There are no primary efficacy endpoints for this study.
  • Safety assessments will comprise an evaluation of the type, nature, frequency and intensity of adverse events during the trial period.
  • No formal statistical analyses of the data will be undertaken. Only descriptive data will be presented. Standard core safety tables will be generated.
Complete list of historical versions of study NCT00372528 on Archive Site
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) ]
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 between each study visit.
No formal statistical analysis of the data will be undertaken. Descriptive data will be presented for seizure frequency (comparison of baseline partial seizure frequency with treatment partial seizure frequency).
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An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.
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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: pregabalin (LYRICA)
150 mg up to a maximum of 600 mg per day bid or tid as required
Experimental: pregabalin
open label treatment
Intervention: Drug: pregabalin (LYRICA)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
  • Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Exclusion Criteria:

  • Is pregnant or is considering becoming pregnant during the course of the study
  • Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Pfizer Call Center Pfizer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP