Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

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NCT00407797

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Study Location
Pfizer Investigational Site
Mexico, D. F., CP 06700, Mexico
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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

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[email protected]

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

- Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

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


- Patients having a treatable cause of seizure, currently receiving vigabatrin, having a
progressive neurological or systemic disorder.

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NCT00407797
  1. Mexico, D. F.
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  11. Montes de Oca, San Jose
  12. San Jose,
  13. Brno 2,
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  15. Hradec Kralove 3,
  16. Olomouc,
  17. Ostrava-Trebovice,
  18. Praha 4,
  19. Pribram 8,
  20. Rychnov nad Kneznou,
  21. Strasbourg Cedex,
  22. Toulouse,
  23. Bonn,
  24. Hamburg,
  25. Athens,
  26. Thessaloniki,
  27. Pune, Maharashtra
  28. Chandigarh, Punjab
  29. Ludhiana, Punjab
  30. Firenze,
  31. Foggia,
  32. Pisa,
  33. Siena,
  34. Busan,
  35. Daejeon,
  36. Seoul,
  37. Seoul,
  38. Seoul,
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  40. Seoul,
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  42. Vilnius,
  43. Distrito Federal,
  44. San Luis Potosi,
  45. Panama,
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  48. Tondo, Manila
  49. Cebu City,
  50. Davao City,
  51. Makati City,
  52. Manila,
  53. Quezon City,
  54. Moscow,
  55. Moscow,
  56. Moscow,
  57. St. Petersburg,
  58. St. Petersburg,
  59. St. Petersburg,
  60. Donostia, Guipuzcoa
  61. Alicante,
  62. Barcelona,
  63. Cordoba,
  64. Girona,
  65. Sevilla,
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ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
Official Title  ICMJE Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin
Brief Summary The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
Detailed Description This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Partial Seizures
Intervention  ICMJE Drug: Pregabalin
150 to 600 mg/day during 21 weeks
Study Arms  ICMJE Experimental: Pregabalin
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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 21, 2009)		136
Original Enrollment  ICMJE
 (submitted: December 1, 2006)		160
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

Exclusion Criteria:

  • Patients having a treatable cause of seizure, currently receiving vigabatrin, 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 Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407797
Other Study ID Numbers  ICMJE A0081090
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 February 2011

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