To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

NCT00141388

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35249, 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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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 Seizure Disorder
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 the 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


- Cannot have absence seizures.

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Partial Seizure DisorderEvaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
NCT00150293
  1. Deakin, Australian Capital Territory
  2. Camperdown, New South Wales
  3. Chastwood, New South Wales
  4. Cairns, Queensland
  5. Maroochydore, Queensland
  6. Footscray, Victoria
  7. Parkville, Victoria
  8. Perth, Western Australia
  9. Auenbruggerplatz 22,
  10. Graz,
  11. Innsbruck,
  12. Linz,
  13. Wien,
  14. Leuven,
  15. Calgary, Alberta
  16. Edmonton, Alberta
  17. Penticton, British Columbia
  18. Vancouver, British Columbia
  19. Halifax, Nova Scotia
  20. Barrie, Ontario
  21. London, Ontario
  22. Ottawa, Ontario
  23. Toronto, Ontario
  24. Windsor, Ontario
  25. Montreal, Quebec
  26. Montreal, Quebec
  27. Montreal, Quebec
  28. Regina, Saskatchewan
  29. Saskatoon, Saskatchewan
  30. Quebec,
  31. Ulm, BW
  32. Berlin,
  33. Bernau,
  34. Bonn,
  35. Dresden,
  36. Erlangen,
  37. Essen,
  38. Frankfurt,
  39. Freiburg,
  40. Goettingen,
  41. Hamburg,
  42. Mainz,
  43. Muenchen,
  44. AE Breda,
  45. Blaricum,
  46. Ve Heeze,
  47. Bialystok,
  48. Bydgoszcz,
  49. Choroszcz,
  50. Gdansk,
  51. Gdansk,
  52. Grudziadz,
  53. Katowice,
  54. Krakow,
  55. Lublin,
  56. Mosina,
  57. Olsztyn,
  58. Plock,
  59. Poznan,
  60. Poznan,
  61. Torun,
  62. Warsaw,
  63. Warsaw,
  64. Warszawa,
  65. Warszawa,
  66. Coimbra,
  67. Porto,
  68. Barcelona,
  69. Girona,
  70. Granada,
  71. Madrid,
  72. Madrid,
  73. Malaga,
  74. Zaragoza,
  75. Middlesborough, N. York
  76. Washington, Tyne & Wear
  77. Blackpool,
  78. Dundee,
  79. Glasgow,
  80. Leeds,
  81. London,
  82. Northampton,
  83. Wolverhampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Partial Seizure DisorderTo Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures
NCT00141388
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Phoenix, Arizona
  5. Tucson, Arizona
  6. Tucson, Arizona
  7. Little Rock, Arkansas
  8. Los Angeles, California
  9. Pasadena, California
  10. Gainesville, Florida
  11. Gainesville, Florida
  12. Miami, Florida
  13. Plantation, Florida
  14. Spring Hill, Florida
  15. Tallahassee, Florida
  16. Chicago, Illinois
  17. Springfield, Illinois
  18. Springfield, Illinois
  19. Indianapolis, Indiana
  20. Indianapolis, Indiana
  21. Iowa City, Iowa
  22. Kansas City, Kansas
  23. Kansas City, Kansas
  24. Louisville, Kentucky
  25. Baltimore, Maryland
  26. Baltimore, Maryland
  27. Greenbelt, Maryland
  28. Boston, Massachusetts
  29. Boston, Massachusetts
  30. Ann Arbor, Michigan
  31. Ann Arbor, Michigan
  32. St. Paul, Minnesota
  33. Chesterfield, Missouri
  34. Columbia, Missouri
  35. St. Louis, Missouri
  36. St. Louis, Missouri
  37. Lebanon, New Hampshire
  38. New York, New York
  39. New York, New York
  40. Rochester, New York
  41. Winston-Salem, North Carolina
  42. Cleveland, Ohio
  43. Columbus, Ohio
  44. Portland, Oregon
  45. Nashville, Tennessee
  46. Dallas, Texas
  47. San Antonio, Texas
  48. Bennington, Vermont
  49. Edmonton, Alberta
  50. Edmont, Alberta
  51. Vancouver, British Columbia
  52. Vancouver, British Columbia
  53. London, Ontario
  54. Ottawa, Ontario
  55. Toronto, Ontario
  56. Montreal, Quebec
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18 Years+
years
MULTIPLE SITES
Partial Seizure DisorderTo Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
NCT00141245
  1. Deakin, Australian Capital Territory
  2. Chatswood, New South Wales
  3. Westmead, New South Wales
  4. Maroochydore, Queensland
  5. Heidelberg,
  6. Woodville,
  7. Graz,
  8. Innsbruck,
  9. Duffel,
  10. Helsinki,
  11. Turku,
  12. Lyon, Cedex
  13. Paris, Cedex
  14. Tours, Cedex
  15. Dijon,
  16. Paris Cedex 13,
  17. Roubaix,
  18. Erlangen,
  19. Freiburg,
  20. Goettingen,
  21. Hamburg,
  22. Mainz,
  23. Moenchengladbach,
  24. Muenster,
  25. Munich,
  26. Firenze,
  27. Pavia,
  28. Perugia,
  29. Pisa,
  30. Heemstede,
  31. Heeze,
  32. Parow, Cape Town
  33. Durban,
  34. San Sebastian, Guipuzcoa
  35. Barcelona,
  36. Gerona,
  37. Sevilla,
  38. Goteborg,
  39. Lavigny, LE,
  40. Tschugg,
  41. Bimingham,
  42. Bucks,
  43. Dundee,
  44. Glasgow,
  45. Liverpool,
  46. York,
ALL GENDERS
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Partial Seizure DisorderTo Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
NCT00141336
  1. Phoenix, Arizona
  2. Tucson, Arizona
  3. Bakersfield, California
  4. Berkeley, California
  5. Concord, California
  6. Covina, California
  7. El Cajon, California
  8. Encino, California
  9. La Mesa, California
  10. Marina del Ray, California
  11. Martinez, California
  12. Northridge, California
  13. Pinole, California
  14. Redondo Beach, California
  15. Sacramento, California
  16. Sacramento, California
  17. San Diego, California
  18. Santa Monica, California
  19. Walnut Creek, California
  20. Denver, Colorado
  21. Englewood, Colorado
  22. Danbury, Connecticut
  23. Miami, Florida
  24. Miami, Florida
  25. Orlando, Florida
  26. Tampa, Florida
  27. Atlanta, Georgia
  28. Chicago, Illinois
  29. Chicago, Illinois
  30. Chicago, Illinois
  31. Crestview Hills, Kentucky
  32. Louisville, Kentucky
  33. Ruston, Louisiana
  34. Baltimore, Maryland
  35. Detroit, Michigan
  36. Golden Valley, Minnesota
  37. Minneapolis, Minnesota
  38. Jackson, Mississippi
  39. St. Louis, Missouri
  40. Las Vegas, Nevada
  41. Las Vegas, Nevada
  42. Concord, New Hampshire
  43. Dover, New Hampshire
  44. New Brunswick, New Jersey
  45. New Brunswick, New Jersey
  46. Ridgewood, New Jersey
  47. Albuquerque, New Mexico
  48. Albuquerque, New Mexico
  49. Albuquerque, New Mexico
  50. Bronx, New York
  51. Brooklyn, New York
  52. New York, New York
  53. Asheville, North Carolina
  54. Asheville, North Carolina
  55. Raleigh, North Carolina
  56. Winston-Salem, North Carolina
  57. Winston-Salem, North Carolina
  58. Cincinnati, Ohio
  59. Cincinnati, Ohio
  60. Columbus, Ohio
  61. Oklahoma City, Oklahoma
  62. Medford, Oregon
  63. Portland, Oregon
  64. Portland, Oregon
  65. Portland, Oregon
  66. Philadelphia, Pennsylvania
  67. Philadelphia, Pennsylvania
  68. Pittsburgh, Pennsylvania
  69. Ridley Park, Pennsylvania
  70. Upland, Pennsylvania
  71. Cranston, Rhode Island
  72. Knoxville, Tennessee
  73. Memphis, Tennessee
  74. Dallas, Texas
  75. Dallas, Texas
  76. Dallas, Texas
  77. Fort Worth, Texas
  78. Fort Worth, Texas
  79. Houston, Texas
  80. Houston, Texas
  81. Houston, Texas
  82. Lubbock, Texas
  83. San Antonio, Texas
  84. San Antonio, Texas
  85. Alexandria, Virginia
  86. Alexandria, Virginia
  87. Charlottesville, Virginia
  88. Roanoke, Virginia
  89. Roanoke, Virginia
  90. Sterling, Virginia
  91. Bellevue, Washington
  92. Bellvue, Washington
  93. Spokane, Washington
  94. Spokane, Washington
  95. Morgantown, West Virginia
  96. Marshfield, Wisconsin
  97. Milwaukee, Wisconsin
  98. Calgary, Alberta
  99. Edmonton, Alberta
  100. Edmonton, Alberta
  101. Barrie, Ontario
  102. London, Ontario
  103. Toronto, Ontario
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures
Official Title  ICMJE Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Brief Summary To evaluate the long-term safety and efficacy 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 Seizure Disorder, 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
Actual Enrollment  ICMJE
 (submitted: November 5, 2009)
455
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
500
Actual Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Cannot have absence seizures.
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141388
Other Study ID Numbers  ICMJE 1008-010
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 November 2009

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