To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

NCT00141414

Last updated date
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Contact
1-800-718-1021

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

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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.
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

- Must have met the inclusion criteria for preceding double-blind study.

- Have received double-blind study medication and wish to receive open-label pregabalin.

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


- Pregnant or considering becoming pregnant.


- Receiving any concomitant medication that could alter the effectiveness of their
medication response or seizure frequency.

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Partial EpilepsyTo Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.
NCT00141414
  1. Little Rock, Arkansas
  2. Los Angeles, California
  3. Stanford, California
  4. Miami, Florida
  5. Plantation, Florida
  6. Indianapolis, Indiana
  7. Indianapolis, Indiana
  8. Baltimore, Maryland
  9. Baltimore, Maryland
  10. Boston, Massachusetts
  11. Ann Arbor, Michigan
  12. St. Paul, Minnesota
  13. Chesterfield, Missouri
  14. Bronx, New York
  15. New York, New York
  16. New York, New York
  17. Rochester, New York
  18. Winston-Salem, North Carolina
  19. Cleveland, Ohio
  20. Columbus, Ohio
  21. Philadelphia, Pennsylvania
  22. Nashville, Tennessee
  23. Madison, Wisconsin
  24. Madison, Wisconsin
  25. Bonn,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Partial EpilepsyStudy Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
NCT00280059
  1. Brugge,
  2. Bruxelles,
  3. Leuven,
  4. Plovdiv,
  5. Sofia,
  6. Sofia,
  7. Sofia,
  8. Varna,
  9. Xi'an, Shanxi
  10. Cheng Du Si Chaun,
  11. Chongqing,
  12. Tian Jin,
  13. Bogota, Cundinamarca
  14. Cali, Valle del Cauca
  15. Brno 2,
  16. Hradec Kralove,
  17. Ostrava,
  18. Pelhrimov,
  19. Praha 4,
  20. Rychnov nad Kneznou,
  21. Zlin,
  22. Tallinn,
  23. Tartu,
  24. Kuopio,
  25. Tampere,
  26. Bordeaux Cedex,
  27. Nancy Cedex,
  28. Strasbourg Cedex,
  29. Berlin,
  30. Bonn,
  31. Essen,
  32. Frankfurt,
  33. Ulm,
  34. Ulm,
  35. Hong Kong,
  36. Kowloon,
  37. Shatin,
  38. Budapest,
  39. Gyor,
  40. Nyiregyhaza,
  41. Bangalore, Karnataka
  42. Indore, Madhya Pradesh
  43. Chennai, Tamil Nadu
  44. Bangalore,
  45. Lucknow,
  46. New Delhi,
  47. Tallaght, Dublin
  48. Bologna,
  49. Firenze,
  50. Foggia,
  51. Pisa,
  52. Daejeon,
  53. Gwangju,
  54. Incheon,
  55. Seoul,
  56. Seoul,
  57. Seoul,
  58. Seoul,
  59. Seoul,
  60. Seoul,
  61. Riga,
  62. Riga,
  63. Kaunas,
  64. Vilnius,
  65. Vilnius,
  66. Mexico, DF
  67. San Luis Potosi,
  68. Den Haag, ZH
  69. Lillehammer,
  70. Trondheim,
  71. Amadora,
  72. Coimbra,
  73. Coimbra,
  74. Porto,
  75. Porto,
  76. Cluj-Napoca, Jud. Cluj
  77. Bucuresti,
  78. Bucuresti,
  79. Singapore,
  80. Bratislava,
  81. Bratislava,
  82. Bratislava,
  83. Kosice,
  84. Zilina,
  85. Badalona, Barcelona
  86. Girona,
  87. Madrid,
  88. Valencia,
  89. Valencia,
  90. Goteborg,
  91. Linkoping,
  92. Uppsala,
  93. Tainan,
  94. Taipei,
  95. Taipei,
  96. Rajthevee, Bangkok
  97. Muang, Khon Kaen
  98. Bangkok,
  99. Stoke-on-Trent, Staffordshire
  100. Glasgow,
  101. Liverpool,
  102. Treliske, Truro, Cornwall,
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.
Official Title  ICMJE Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.
Brief Summary To evaluate the long-term safety of pregabalin in refractory partial epilepsy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, 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: August 30, 2005)
82
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have met the inclusion criteria for preceding double-blind study.
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Pregnant or considering becoming pregnant.
  • Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.
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 Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141414
Other Study ID Numbers  ICMJE 1008-008
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 December 2006

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