Once-A-Day Pregabalin For Partial Seizures

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NCT01262677

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Study Location
Neurology Clinic, PC
Northport, Alabama, 35476, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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

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

- Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)

- Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

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


- Primary generalized seizures (for example, absence, myoclonic seizures or
Lennox-Gastaut Syndrome)


- Status epilepticus within one year prior to screening

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Partial Seizures, Partial EpilepsiesOnce-A-Day Pregabalin For Partial Seizures
NCT01262677
  1. Northport, Alabama
  2. Jonesboro, Arkansas
  3. Little Rock, Arkansas
  4. Long Beach, California
  5. Murrieta, California
  6. Murrieta, California
  7. Santa Monica, California
  8. Temecula, California
  9. Gainesville, Florida
  10. Gainesville, Florida
  11. Gainesville, Georgia
  12. Springfield, Illinois
  13. Wichita, Kansas
  14. Wichita, Kansas
  15. Lexington, Kentucky
  16. Pikesville, Maryland
  17. Asheville, North Carolina
  18. Oklahoma City, Oklahoma
  19. Oklahoma City, Oklahoma
  20. Oklahoma City, Oklahoma
  21. Oklahoma City, Oklahoma
  22. Oklahoma City, Oklahoma
  23. Philadelphia, Pennsylvania
  24. Austin, Texas
  25. Temple, Texas
  26. Temple, Texas
  27. Ciudad Autonoma de Buenos Aires,
  28. Sarajevo,
  29. Blagoevgrad,
  30. Pleven,
  31. Sevlievo,
  32. Sofia,
  33. Sofia,
  34. Litomysl,
  35. Praha 4,
  36. Praha 6,
  37. Bielefeld,
  38. Bielefeld,
  39. Bonn,
  40. Duesseldorf,
  41. Kehl-Kork,
  42. Muenchen,
  43. Hong Kong,
  44. Kowloon,
  45. Balassagyarmat,
  46. Budapest,
  47. Budapest,
  48. Dunaujvaros,
  49. Guntur, Andhra Pradesh
  50. Mysore, Karnataka
  51. Pune, Maharashtra
  52. Pune, Maharashtra
  53. Pune, Maharashtra
  54. Pune, Maharashtra
  55. Pune, Maharashtra
  56. Nehru Nagar, NEW Delhi
  57. Kubang Kerian, Kelantan
  58. Kelantan Darul Naim,
  59. Kuala Lumpur,
  60. Delagación Cuauhtemoc, DF
  61. Guadalajara, Jalisco
  62. Monterrey, Nuevo LEON
  63. Culiacan, Sinaloa
  64. Aguascalientes,
  65. Gdansk,
  66. Krakow,
  67. Lodz,
  68. Swidnik,
  69. San Juan,
  70. Iasi, Jud. Iasi
  71. Bucuresti,
  72. Barnaul,
  73. Kazan,
  74. Moscow,
  75. Pyatigorsk,
  76. Saint-Petersburg,
  77. Samara,
  78. Belgrade,
  79. Singapore,
  80. Singapore,
  81. Muang, Khon Kaen
  82. Bangkok,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Once-A-Day Pregabalin For Partial Seizures
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures
Brief Summary Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Seizures
  • Epilepsies, Partial
Intervention  ICMJE
  • Drug: pregabalin
    Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
  • Drug: pregabalin
    Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
  • Drug: pregabalin
    Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
  • Drug: pregabalin
    Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
  • Drug: pregabalin
    Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
  • Drug: placebo
    matched to the active drug
Study Arms  ICMJE
  • Experimental: pregabalin CR 330 mg
    Interventions:
    • Drug: pregabalin
    • Drug: pregabalin
    • Drug: pregabalin
    • Drug: pregabalin
  • Experimental: pregabalin CR 165 mg
    Interventions:
    • Drug: pregabalin
    • Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.

*   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: May 3, 2018)		325
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2010)		333
Actual Study Completion Date  ICMJE August 1, 2012
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
  • Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

  • Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
  • Status epilepticus within one year prior to screening
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 Argentina,   Bosnia and Herzegovina,   Bulgaria,   Czechia,   Germany,   Hong Kong,   Hungary,   India,   Malaysia,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Thailand,   United States
Removed Location Countries Croatia,   Czech Republic,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT01262677
Other Study ID Numbers  ICMJE A0081194
2010-019035-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 April 2018

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