Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

Back to Search
Print
Bookmark Trial

NCT00596466

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85003, United States
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

- Completed the previous protocol and wish to continue to receive pregabalin.

- Diagnosis of epilepsy with partial seizures

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


- Early withdrawal from the previous protocol, an episode of status epliepticus, or
primary generalized epilepsy.

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
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

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 Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Official Title  ICMJE An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Brief Summary This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
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
pregabalin
Study Arms  ICMJE Experimental: 1
Intervention: Drug: pregabalin
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)		75
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2008)		250
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completed the previous protocol and wish to continue to receive pregabalin.
  • Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

  • Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
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 Czechia,   Hong Kong,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00596466
Other Study ID Numbers  ICMJE A0081160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2012

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