Pregabalin In Partial Seizures Extension Study

NCT00143130

Last updated date
Study Location
Pfizer Investigational Site
Brugge, , B-8000, Belgium
Contact
1-800-718-1021

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]

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

- met the inclusion/exclusion criteria for A0081005

- have completed the 21-week study and have shown a significant clinical response and wish to continue treatment

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


- Having a treatable cause of seizure.


- Having a progressive neurological or systemic disorder

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  1. Brugge,
  2. Brussels,
  3. Duffel,
  4. Gent,
  5. Leuven,
  6. Liege,
  7. Tielt,
  8. Yvoir,
  9. Helsinki,
  10. Kuopio,
  11. Tampere,
  12. Marseille, Cedex 05
  13. Montpellier, Cedex 5
  14. Lyon, Cedex
  15. Bayonne,
  16. Bordeaux Cedex,
  17. Grenoble Cedex,
  18. Lille Cedex,
  19. Marseille,
  20. Nancy,
  21. Nice Cedex,
  22. Paris,
  23. Paris,
  24. Paris,
  25. Rennes,
  26. Strasbourg,
  27. Toulouse,
  28. Tours,
  29. Den Haag, ZH
  30. Alkmaar,
  31. Breda,
  32. Heeze,
  33. Hilversum,
  34. Oss,
  35. SW Heemstede,
  36. Katowice,
  37. Krakow,
  38. Lublin,
  39. Warszawa,
  40. Warszawa,
  41. Warszawa,
  42. Wroclaw,
  43. Braga,
  44. Funchal,
  45. Lisboa,
  46. Matosinhos,
  47. Ponta Delgada,
  48. Porto,
  49. Lausanne,
  50. Zurich,
  51. Zurich,
  52. Cambridge, Cambs
  53. Truro, Cornwall
  54. Plymouth, Devon
  55. Glasgow,
  56. Oxford,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SeizuresPregabalin In Partial Seizures Extension Study NCT00143130
  1. Brugge,
  2. Brussels,
  3. Duffel,
  4. Gent,
  5. Leuven,
  6. Liege,
  7. Tielt,
  8. Yvoir,
  9. Helsinki,
  10. Kuopio,
  11. Tampere,
  12. Paris, Cedex 14
  13. Lille, Cedex
  14. Lyon, Cedex
  15. Marsille, Cedex
  16. Rennes, Cedex
  17. Bayonne,
  18. Bordeaux Cedex,
  19. Grenoble Cedex,
  20. Marseille 13,
  21. Montpellier Cedex 5,
  22. Nancy,
  23. Nice,
  24. Paris Cedex 13,
  25. Paris Cedex 14,
  26. Paris,
  27. Strasbourg,
  28. Toulouse,
  29. Tours Cedex,
  30. Katowice,
  31. Krakow,
  32. Lublin,
  33. Warszawa,
  34. Warszawa,
  35. Warszawa,
  36. Wroclaw,
  37. Braga,
  38. Coimbra,
  39. Funchal,
  40. Lisboa,
  41. Matosinhos,
  42. Ponta Delgada,
  43. Ponta Delgada,
  44. Porto,
  45. Lausanne,
  46. Zurich,
  47. Zurich,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin In Partial Seizures Extension Study
Official Title  ICMJE Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
Brief Summary To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment 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 Seizures
Intervention  ICMJE Drug: Pregabalin
Pregabalin
Study Arms  ICMJE Experimental: Single Arm
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: December 18, 2007)
227
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
500
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • met the inclusion/exclusion criteria for A0081005
  • have completed the 21-week study and have shown a significant clinical response and wish to continue treatment

Exclusion Criteria:

  • Having a treatable cause of seizure.
  • Having a progressive neurological or systemic disorder
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 Belgium,   Finland,   France,   Poland,   Portugal,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143130
Other Study ID Numbers  ICMJE A0081015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

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