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

Last updated on October 11, 2019

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Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00372528
Pfizer
Terminated
An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

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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 SummaryThe 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 DescriptionNot 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 DateOctober 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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