Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

NCT00143143

Last updated date
Study Location
Pfizer Investigational Site
Innsbruck, , A6020, Austria
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies, Complex Partial 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

- Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin

- Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening

- Be currently taking 1 to 3 AEDs.

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


- Have a treatable cause of seizures


- Experienced a serious adverse event during Study 1008-157 which was determined to be
possibly related to study medication

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Partial Epilepsies, Complex Partial EpilepsyPregabalin Open-Label Extension Trial in Patients With Partial Seizures
NCT00143143
  1. Innsbruck,
  2. Mauer Bei Amstetten,
  3. St Polten,
  4. Wien,
  5. Calgary, Alberta
  6. Edmonton, Alberta
  7. Vancouver, British Columbia
  8. Halifax, Nova Scotia
  9. Barrie, Ontario
  10. London, Ontario
  11. Ottawa, Ontario
  12. Trois Rivieres, Quebec
  13. Marseille, Cedex 05
  14. Paris, Cedex 13
  15. Montpellier, Cedex 5
  16. Lille, Cedex
  17. Rennes, Cedex
  18. Colomiers,
  19. Dommartin Les Toul,
  20. Marseille Cedex 09,
  21. Strasbourg,
  22. Berlin,
  23. Berlin,
  24. Bielefeld,
  25. Bonn,
  26. Essen,
  27. Frankfurt,
  28. Freiburg,
  29. Goettingen,
  30. Kehl,
  31. Marburg,
  32. ULM,
  33. Firenze,
  34. Perugia,
  35. Pisa,
  36. Siena,
  37. Vilnius,
  38. Vilnius,
  39. Barcelona,
  40. Donostia-San Sebastian,
  41. Gerona,
  42. Madrid,
  43. Madrid,
  44. Glascow, Scotland
  45. Fazakerley, Liverpool,
  46. York,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
Official Title  ICMJE Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
Brief Summary The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with 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
  • Epilepsies, Partial
  • Epilepsy, Complex Partial
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: September 1, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
  • Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
  • Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

  • Have a treatable cause of seizures
  • Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
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 Austria,   Canada,   France,   Germany,   Italy,   Lithuania,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143143
Other Study ID Numbers  ICMJE 1008-000-164
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2006

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