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

Back to Search
Print
Bookmark Trial

NCT00372528

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9, Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

EpilepsyExtension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures NCT00596466
  1. Phoenix, Arizona
  2. Fayetteville, Arkansas
  3. Fullerton, California
  4. Long Beach, California
  5. Modesto, California
  6. Murrieta, California
  7. Newport Beach, California
  8. Temecula, California
  9. Denver, Colorado
  10. Jacksonville, Florida
  11. Suwanee, Georgia
  12. Danville, Indiana
  13. Fort Wayne, Indiana
  14. Kansas City, Kansas
  15. Bowling Green, Kentucky
  16. Lexington, Kentucky
  17. Houma, Louisiana
  18. Shreveport, Louisiana
  19. Pikesville, Maryland
  20. Worcester, Massachusetts
  21. Detroit, Michigan
  22. Flowood, Mississippi
  23. Great Falls, Montana
  24. Charlotte, North Carolina
  25. Charlotte, North Carolina
  26. Columbus, Ohio
  27. Oklahoma City, Oklahoma
  28. Oklahoma City, Oklahoma
  29. Dallas, Texas
  30. Houston, Texas
  31. Temple, Texas
  32. Salt Lake City, Utah
  33. West Jordan, Utah
  34. Milwaukee, Wisconsin
  35. Beroun,
  36. Brno 2,
  37. Litomysl,
  38. New Territories,
  39. Dnipropetrovsk,
  40. Dnipropetrovsk,
  41. Kharkiv,
  42. Kharkiv,
  43. Lugansk,
  44. Odessa,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
EpilepsyA Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients NCT00979004
  1. Little Rock, Arkansas
  2. Chesterfield, Missouri
  3. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
EpilepsyLyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER). NCT00288639
  1. Athens,
  2. Athens,
  3. Heraklio,
  4. Mesogion, Athen,
  5. Patras,
  6. Thessaloniki,
  7. Thessaloniki,
  8. Thessaloniki,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
EpilepsyAn Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures NCT00372528
  1. Calgary, Alberta
  2. Halifax, Nova Scotia
  3. Barrie, Ontario
  4. Toronto, Ontario
  5. Windsor, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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