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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 7, 2006
Results First Submitted Date  ICMJE September 21, 2012
Results First Posted Date  ICMJE October 23, 2012
Last Update Posted Date October 23, 2012
Study Start Date  ICMJE March 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • 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.
Change History Complete list of historical versions of study NCT00372528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: pregabalin (LYRICA)
150 mg up to a maximum of 600 mg per day bid or tid as required
Study Arms  ICMJE Experimental: pregabalin
open label treatment
Intervention: Drug: pregabalin (LYRICA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 15, 2011)
21
Original Enrollment  ICMJE
 (submitted: September 6, 2006)
35
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372528
Other Study ID Numbers  ICMJE A0081140
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2012

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